Updated on 2025/08/12

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写真a

 
Haruo Miwa
 
Organization
YCU Medical Center Gastroenterological Center Lecturer
Title
Lecturer
External link

Degree

  • Ph.D. ( 2016.8   Yokohama City University )

Research Areas

  • Life Science / Gastroenterology  / 膵臓

  • Life Science / Gastroenterology  / 胆道

  • Life Science / Radiological sciences  / 超音波

Education

  • Shinshu University   School of Medicine

    2000.4 - 2006.3

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    Country: Japan

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Papers

  • Non-tip and rotatable sphincterotome for biliary cannulation in patients with Roux-en-Y gastrectomy

    Haruo Miwa, Kazuya Sugimori, Kazuki Endo, Ritsuko Oishi, Hiromi Tsuchiya, Takashi Kaneko, Shin Maeda

    Endoscopy   2024.12

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    DOI: 10.1055/a-2239-2558

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  • Pancreatic pseudocyst with biliary fistula diagnosed using a novel slim peroral cholangioscope

    Haruo Miwa, Kazuya Sugimori, Kazuki Endo, Ritsuko Oishi, Hiromi Tsuchiya, Takashi Kaneko, Shin Maeda

    Endoscopy   2024.12

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    DOI: 10.1055/a-2253-8912

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  • Endoscopic hemostasis with bipolar forceps coagulation for post-endoscopic sphincterotomy bleeding

    Haruo Miwa, Kazuya Sugimori, Kazuki Endo, Ritsuko Oishi, Hiromi Tsuchiya, Takashi Kaneko, Shin Maeda

    Endoscopy   2024.12

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    Publishing type:Research paper (scientific journal)  

    DOI: 10.1055/a-2291-9399

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  • Differential Diagnosis of Solid Pancreatic Lesions Using Detective Flow Imaging Endoscopic Ultrasonography

    Haruo Miwa, Kazuya Sugimori, Shoichiro Yonei, Hayato Yoshimura, Kazuki Endo, Ritsuko Oishi, Akihiro Funaoka, Hiromi Tsuchiya, Takashi Kaneko, Kazushi Numata, Shin Maeda

    Diagnostics   2024.4

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    Publishing type:Research paper (scientific journal)  

    DOI: 10.3390/diagnostics14090882

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  • Novel peroral cholangioscopy‐guided electrohydraulic lithotripsy for difficult stones

    Haruo Miwa, Kazuya Sugimori, Hayato Yoshimura, Kazuki Endo, Ritsuko Oishi, Akihiro Funaoka, Hiromi Tsuchiya, Takashi Kaneko, Kazushi Numata, Shin Maeda

    Journal of Hepato-Biliary-Pancreatic Sciences   2024.2

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    DOI: 10.1002/jhbp.1385

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  • Loop technique for guidewire manipulation during endoscopic ultrasound-guided hepaticogastrostomy. International journal

    Haruo Miwa, Kazuya Sugimori, Yuto Matsuoka, Kazuki Endo, Ritsuko Oishi, Masaki Nishimura, Yuichiro Tozuka, Takashi Kaneko, Kazushi Numata, Shin Maeda

    JGH open : an open access journal of gastroenterology and hepatology   7 ( 5 )   358 - 364   2023.5

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    BACKGROUND AND AIM: Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is widely used in the management of biliary obstructions; however, literature on guidewire manipulation is lacking. This study aimed to assess the utility and optimal conditions of the loop technique for guidewire manipulation during EUS-HGS. METHODS: Consecutive patients who underwent EUS-HGS between April 2015 and January 2022 were included in this study. Patient characteristics and procedural details were retrospectively analyzed. Guidewire manipulations were classified as conventional technique or loop technique, based on the shape of the guidewire tip. RESULTS: A total of 52 patients (Median age: 73 years, 38 male and 14 female) underwent EUS-HGS. The median guidewire insertion time was 49 s and the median overall procedure time was 20.5 min. The initial guidewire direction was toward the peripheral side in 23 patients (44%). Technical success rate of the EUS-HGS was 100%. Twenty patients (38%) underwent the procedure using the loop technique and 32 (62%) with the conventional technique. In the logistic regression analysis, an angle between the bile duct and needle of >70° was independently associated with use of the loop technique (OR 9.84; 95% CI: 2.24-43.13; P <0.01). CONCLUSION: This study revealed the utility of the loop technique in EUS-HGS. This technique is recommended if the bile duct is punctured at an angle >70°.

    DOI: 10.1002/jgh3.12903

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  • Vessel images of gallbladder polypoid lesions on detective flow imaging endoscopic ultrasonography. International journal

    Haruo Miwa, Kazuya Sugimori, Shin Maeda

    Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society   35 ( 4 )   e61-e62   2023.5

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    DOI: 10.1111/den.14530

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  • Novel clip device for prevention of bleeding after endoscopic papillectomy. International journal

    Haruo Miwa, Kazuya Sugimori, Hiromi Tsuchiya, Makoto Sugimori, Masaki Nishimura, Yuichiro Tozuka, Satoshi Komiyama, Takeshi Sato, Takashi Kaneko, Kazushi Numata, Shin Maeda

    DEN open   2 ( 1 )   e51   2022.4

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    Objectives: Recently, a novel clip device, SureClip® (Micro-Tech Co. Ltd., Nanjing, China), has been developed, which improved rotation and reopening performance. We aimed to assess the efficacy of the SureClip® in prophylactic closure of the mucosal break after endoscopic papillectomy (EP) for ampullary neoplasm. Methods: We retrospectively reviewed the medical records of 40 patients who underwent EP for ampullary neoplasms between October 2009 and March 2020. Prophylactic closure after resection was performed using the conventional clip between 2014 and 2018, and with the SureClip® after 2019. The baseline characteristics, techniques, outcomes, and complications of EP were analyzed. Results: The median age of the patients (25 males and 15 females) was 70 years. The en block resection rate was 82.5% and the curative resection rate was 80.0%. Histologically, 11 (27.5%) patients had malignancy. Prophylactic closure was performed in 29 (72.5%) patients (17 conventional clips, 12 SureClip®). Complications occurred in 18 (45.0%) patients, including postprocedure bleeding in 9 (22.5%) patients. However, no postprocedure bleeding was observed in the patients who received prophylactic closure using the SureClip® (p = 0.038). All other factors were not significantly correlated with postprocedure bleeding. The duration of hospital stay after EP was significantly shorter in patients treated with the SureClip® compared to those treated with a conventional clip or without clips (p < 0.05). Conclusions: In the present study, prophylactic clipping of the mucosal break using the SureClip® was effective in preventing bleeding after EP.

    DOI: 10.1002/deo2.51

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  • Multiple-line Chemotherapy for a Patient with Unresectable Mucinous Cystic Neoplasm of the Pancreas.

    Haruo Miwa, Kazuya Sugimori, Tomohiro Ishii, Akihiro Funaoka, Hiromi Tsuchiya, Yoshimasa Suzuki, Makoto Sugimori, Masaki Nishimura, Yuichiro Tozuka, Satoshi Komiyama, Takeshi Sato, Takashi Kaneko, Kazushi Numata, Shin Maeda

    Internal medicine (Tokyo, Japan)   60 ( 16 )   2607 - 2612   2021.8

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    A 74-year-old woman with a cyst in her pancreatic tail was referred to our hospital. Computed tomography confirmed a large cystic lesion with irregular wall thickening, abdominal lymph node swelling, and ascites. We diagnosed her with an unresectable mucinous cystic neoplasm, since ascites cytology revealed adenocarcinoma. The patient received chemotherapy up to the fifth line for 55.2 months. Gemcitabine plus nab-paclitaxel and modified FOLFIRINOX achieved a partial response with a progression-free survival time of 12.1 and 20.4 months, respectively. The overall survival time from the beginning of first-line chemotherapy was 69.4 months.

    DOI: 10.2169/internalmedicine.6755-20

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  • Safe removal of lumen-apposing metal stent using argon plasma coagulation after EUS-guided cyst gastrostomy (with video). International journal

    Haruo Miwa, Kazuya Sugimori, Hiromi Tsuchiya, Masaki Nishimura, Yuichiro Tozuka, Takashi Kaneko, Shin Maeda

    Endoscopic ultrasound   10 ( 4 )   309 - 310   2021

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    DOI: 10.4103/EUS-D-20-00211

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  • Clinical outcome of a highly flexible duodenal stent for gastric outlet obstruction: A multicenter prospective study. International journal

    Haruo Miwa, Kazuya Sugimori, Takashi Kaneko, Tomohiro Ishii, Shigeru Iwase, Kuniyasu Irie, Katsuyuki Sanga, Yuichiro Tozuka, Akane Hirotani, Satoshi Komiyama, Takeshi Sato, Shun Tezuka, Yoshihiro Goda, Kazushi Numata, Shin Maeda

    JGH open : an open access journal of gastroenterology and hepatology   4 ( 4 )   729 - 735   2020.8

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    Background and Aim: Endoscopic duodenal stenting for patients with malignant gastric outlet obstruction (GOO) has been widespread; however, clinical trials evaluating the structures of duodenal stents are lacking. Thus, we aimed to investigate the clinical outcomes of a highly flexible duodenal stent for GOO patients. Methods: A prospective study of duodenal stenting for GOO patients from five hospitals between August 2017 and August 2018 was performed. WallFlex Duodenal Soft were used in all procedures. The primary endpoint was clinical success, defined as an improvement in the GOO scoring system. Results: The study enrolled 31 patients (12 women, 19 men) with GOO, with a median age of 70 (range 52-90) years. Primary diseases were pancreatic cancer, gastric cancer, biliary tract cancer, and others in 14, 10, 3, and 4 patients, respectively. The technical success rate was 97%, and the clinical success rate was 87%. Simultaneous biliary drainage was performed in 19% of patients. Adverse events occurred in three patients. Chemotherapy was given in 41% of clinically successful cases, and the median overall survival time after stent placement was 82 days (range, 30-341 days), and. Stent dysfunction occurred in 30% of clinically successful cases (stent ingrowth in seven and stent overgrowth in one patient). The median time to stent dysfunction was 157 days (range, 11-183 days). Six patients were treated with additional stent placement after dysfunction. Conclusion: Placement of a highly flexible duodenal stent is an effective and safe treatment for patients with GOO (UMIN-CTR 000028783).

    DOI: 10.1002/jgh3.12326

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  • Biliary stent removal through a transgastric fistula created with endoscopic ultrasound-guided hepaticogastrostomy.

    Haruo Miwa, Kazuya Sugimori, Yuichiro Ozeki, Katsuyuki Sanga, Akane Hirotani, Shun Tezuka, Yoshihiro Goda, Kazushi Numata, Shin Maeda

    Clinical journal of gastroenterology   14 ( 1 )   304 - 308   2020.7

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    Therapeutic endoscopic ultrasound has become widespread as an effective procedure for biliary drainage; however, it is rarely used to remove foreign bodies such as a biliary stent. A 57-year-old man was referred to our hospital for a benign biliary stricture in the left hepatic duct after hepatectomy. Initially, a 7-Fr plastic stent was placed in the left hepatic duct with the distal end set above the papilla, and it was replaced with an 8.5-Fr stent as the stricture remained after 3 months. Endoscopic retrograde cholangiopancreatography was performed to retrieve the plastic stent 3 months later; however, the stent could not be moved because the proximal flap was caught in the stricture. Attempts using various devices failed to retrieve the stent; thus, endoscopic ultrasound-guided hepaticogastrostomy was performed to create a route for stent retrieval. Eventually, the plastic stent was successfully retrieved with biopsy forceps through a fully covered self-expandable metallic stent located in a transgastric fistula. We propose our new method involving endoscopic ultrasound-guided hepaticogastrostomy for endoscopic stent retrieval that fails via the transpapillary route.

    DOI: 10.1007/s12328-020-01184-7

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  • Internal drainage by cutting the nasobiliary tube after endoscopic ultrasound-guided hepaticogastrostomy. International journal

    Haruo Miwa, Kazuya Sugimori, Shin Maeda

    Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society   32 ( 4 )   e75-e76   2020.5

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    DOI: 10.1111/den.13648

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  • Vascular evaluation using transabdominal ultrasound for gallbladder polyps.

    Haruo Miwa, Kazushi Numata, Kazuya Sugimori, Takashi Kaneko, Shin Maeda

    Journal of medical ultrasonics (2001)   48 ( 2 )   159 - 173   2020.3

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    Ultrasound (US) is a cost-effective and noninvasive procedure without radiation exposure, with real-time evaluation and high spatial resolution. Although it is useful for the detection of gallbladder (GB) polyps, including gallbladder cancer, adenoma, and benign polyps, conventional US is insufficient for differential diagnosis because it is not capable of evaluating hemodynamic information, unlike computed tomography or magnetic resonance imaging. With recent technological advances in US equipment and contrast agents, Doppler imaging and contrast-enhanced ultrasonography (CEUS) are being used to characterize GB polyps, and several reports on evaluation of the vascularity of GB polyp have been published. In this review, we aimed to report the latest developments in the hemodynamic diagnosis of GB polyps based on previous reports, with an emphasis on CEUS, and to evaluate the efficacy for differential diagnosis. The information in this article is expected to enable early diagnosis and prompt surgical treatment for gallbladder cancer.

    DOI: 10.1007/s10396-020-01008-8

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  • Differential diagnosis of gallbladder polypoid lesions using contrast-enhanced ultrasound. International journal

    Haruo Miwa, Kazushi Numata, Kazuya Sugimori, Katsuyuki Sanga, Akane Hirotani, Shun Tezuka, Yoshihiro Goda, Kuniyasu Irie, Tomohiro Ishii, Takashi Kaneko, Katsuaki Tanaka, Shin Maeda

    Abdominal radiology (New York)   44 ( 4 )   1367 - 1378   2019.4

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    PURPOSE: The purpose of the study is to evaluate the utility of contrast-enhanced ultrasound (CEUS) for the differential diagnosis of gallbladder polypoid lesions (GPLs). METHODS: Thirty-six patients with GPLs (17 with gallbladder cancer, 19 with benign polyps) who underwent CEUS were enrolled in the study. The mean age of patients was 65.7 ± 12.6 years. Perflubutane-based contrast agent and high-mechanical index mode, which can eliminate the background B-mode and provide precise visualization of tumor vessels, were used for CEUS, and two blinded readers evaluated the images, retrospectively. RESULTS: Patient age and size of malignant GPLs (72.4 ± 9.4 years and 23.4 ± 7.5 mm) were significantly greater than those for benign lesions (59.6 ± 12.3 years and 12.4 ± 2.9 mm) (P < 0.01, respectively), and the receiver operating characteristic analysis showed the cut-off value as over 65 years and 16 mm. Univariate analysis showed that heterogeneity in B-mode (80% [12/15]), sessile shape (76% [13/17]), dilated vessel (71% [12/17]), irregular vessel (82% [14/17]), and heterogeneous enhancement (59% [10/17]) on CEUS were significantly correlated with malignant GPLs (P < 0.01, respectively). On CEUS, the diagnostic criterion for malignant GPLs was defined as having one or more of the above four features because of the highest accuracy. Sensitivity, specificity, and accuracy for malignant GBLs were 88%, 68%, and 78% for patient age; 76%, 89%, and 83% for size of GPLs; 80%, 68%, and 74% for B-mode; and 94%, 89%, and 92% for CEUS, respectively. CONCLUSIONS: CEUS is useful for the differential diagnosis of malignant and benign GPLs.

    DOI: 10.1007/s00261-018-1833-4

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  • Differential diagnosis of solid pancreatic lesions using contrast-enhanced three-dimensional ultrasonography. International journal

    Haruo Miwa, Kazushi Numata, Kazuya Sugimori, Takashi Kaneko, Kentaro Sakamaki, Michio Ueda, Hiroyuki Fukuda, Katsuaki Tanaka, Shin Maeda

    Abdominal imaging   39 ( 5 )   988 - 99   2014.10

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    PURPOSE: To investigate the usefulness of contrast-enhanced three-dimensional ultrasonography (CE 3D US) for differential diagnosis of solid pancreatic lesions. METHODS: Eighty-five patients with solid pancreatic lesions who underwent CE 3D US were retrospectively analyzed. Sixty-four patients had pancreatic ductal adenocarcinoma (PDAC), 10 had mass-forming pancreatitis (MFP), and 11 had neuroendocrine tumor (NET). Two blinded readers evaluated the enhancement patterns using four features: vascularity in the arterial phase, vascularity in the venous phase, vessel location, and vessel form. Vascularity in both phases was classified as hypervascular, isovascular, or hypovascular. Vessel location was classified into peritumoral or intratumoral. Vessel form was classified into fine or irregular. Kappa values were used to assess inter-reader agreement. The institutional review board approved this study, and informed consent was obtained. RESULTS: Kappa values of the four features were 0.75, 0.72, 0.85, and 0.65, which were graded as good or excellent. The most typical combined enhancement pattern in PDAC was hypovascularity in both phases with peritumoral and irregular vessels; MFP was isovascular in both phases with intratumoral and fine vessels; and NETs were hypervascular in both phases with intratumoral and irregular vessels. The sensitivity and positive predictive value of the three patterns were 93.8% and 96.7% for the PDAC pattern, 80.0% and 100% for the MFP pattern, and 81.8%, and 69.2% for the NET pattern, respectively. The accuracy of these diagnostic criteria was 90.5%. CONCLUSION: CE 3D US allows detailed visualization of the enhancement patterns of various pancreatic lesions and can be used for the differential diagnosis.

    DOI: 10.1007/s00261-014-0135-8

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  • Feasibility of Novel Slim Peroral Cholangiopancreatoscopy for the Diagnosis of Pancreatobiliary Disease

    Haruo Miwa, Kazuya Sugimori, Kuniyasu Irie, Yoshihiro Goda, Kozue Shibasaki, Yugo Ishino, Shotaro Tsunoda, Kazuki Endo, Ritsuko Oishi, Yuichi Suzuki, Hiromi Tsuchiya, Akihiro Funaoka, Hideyuki Anan, Yoshimasa Suzuki, Takashi Kaneko, Manabu Morimoto, Kazushi Numata, Shin Maeda

    DEN Open   2026.4

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    DOI: 10.1002/deo2.70152

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  • Novel self-expandable metal stent with dumbbell-shape and spiral cover to prevent stent-related cholecystitis

    Haruo Miwa, Yugo Ishino, Shotaro Tsunoda, Ritsuko Oishi, Kazuki Endo, Yuichi Suzuki, Shin Maeda

    Endoscopy   2025.12

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    DOI: 10.1055/a-2559-9546

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  • Endoscopic ultrasound-guided hepaticogastrostomy without tract dilation using a novel ultra-tapered slim-delivery metallic stent

    Ritsuko Oishi, Haruo Miwa, Kazuki Endo, Hiromi Tsuchiya, Yuichi Suzuki, Kazushi Numata, Shin Maeda

    Endoscopy   2025.12

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    DOI: 10.1055/a-2552-0373

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  • Scope withdrawal technique to prevent transesophageal puncture during endoscopic ultrasound-guided hepaticogastrostomy

    Kazuki Endo, Haruo Miwa, Ritsuko Oishi, Hiromi Tsuchiya, Yuichi Suzuki, Kazushi Numata, Shin Maeda

    Endoscopy   2025.12

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    DOI: 10.1055/a-2623-6215

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  • Novel methods to confirm successful puncture in endoscopic ultrasound-guided hepaticogastrostomy

    Haruo Miwa, Ritsuko Oishi, Shotaro Tsunoda, Yuichi Suzuki, Kazuki Endo, Hiromi Tsuchiya, Shin Maeda

    Endoscopy   2025.12

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    DOI: 10.1055/a-2521-4987

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  • Endoscopic papillary large balloon dilation with a novel non-slip balloon in a patient with surgically altered anatomy. International journal

    Haruo Miwa, Yuichi Suzuki, Kazuki Endo, Ritsuko Oishi, Hiromi Tsuchiya, Kazushi Numata, Shin Maeda

    Endoscopy   57 ( S 01 )   E7-E8   2025.12

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    DOI: 10.1055/a-2499-7613

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  • A novel reshapable catheter facilitates selective biliary and pancreatic duct cannulation following endoscopic submucosal dissection including papilla

    Haruo Miwa, Kingo Hirasawa, Kazuki Endo, Ritsuko Oishi, Yuichi Suzuki, Hiromi Tsuchiya, Shin Maeda

    Endoscopy   2025.12

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    DOI: 10.1055/a-2598-5509

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  • Endoscopic ultrasound-guided hepaticogastrostomy without tract dilation using a novel 0.035-inch guidewire

    Ritsuko Oishi, Haruo Miwa, Kazuki Endo, Hiromi Tsuchiya, Yuichi Suzuki, Kazushi Numata, Shin Maeda

    Endoscopy   2025.12

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    DOI: 10.1055/a-2535-1881

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  • Endoscopic ultrasonography-guided hepaticoduodenostomy using a novel self-expandable metallic stent with an ultra-tapered tip and a slim-delivery system

    Haruo Miwa, Yugo Ishino, Kazuki Endo, Ritsuko Oishi, Yuichi Suzuki, Yusuke Suwa, Shin Maeda

    Endoscopy   2025.12

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    DOI: 10.1055/a-2590-8508

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  • Endoscopic ultrasound-guided tissue acquisition using a novel Franseen needle for ampullary gangliocytic paraganglioma

    Yuichi Suzuki, Haruo Miwa, Kazuki Endo, Ritsuko Oishi, Hiromi Tsuchiya, Manabu Morimoto, Shin Maeda

    Endoscopy   2025.12

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    DOI: 10.1055/a-2643-8870

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  • Anchoring wire technique for additional stent placement after endoscopic ultrasonography-guided hepaticogastrostomy

    Kazuki Endo, Haruo Miwa, Ritsuko Oishi, Yuichi Suzuki, Kazuya Sugimori, Kazushi Numata, Shin Maeda

    Endoscopy   2025.12

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    DOI: 10.1055/a-2643-8405

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  • Endoscopic ultrasonography-guided choledochoduodenostomy without tract dilation using a novel ultra-tapered slim-delivery metallic stent.

    Haruo Miwa, Ritsuko Oishi, Shotaro Tsunoda, Kazuki Endo, Yuichi Suzuki, Hiromi Tsuchiya, Shin Maeda

    Endoscopy   2025.12

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    DOI: 10.1055/a-2607-8148

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  • Endoscopic ultrasonography-guided hepaticogastrostomy with a novel 0.018-inch guidewire and a slim-delivery metallic stent

    Shotaro Tsunoda, Haruo Miwa, Hiromi Tsuchiya, Kazuki Endo, Ritsuko Oishi, Yuichi Suzuki, Shin Maeda

    Endoscopy   2025.12

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    DOI: 10.1055/a-2608-0713

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  • Antegrade stone removal using a novel non‐slip balloon for dilation in a patient with hepaticojejunostomy anastomosis

    Haruo Miwa, Ritsuko Oishi, Shin Maeda

    Journal of Hepato-Biliary-Pancreatic Sciences   2025.5

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    DOI: 10.1002/jhbp.12116

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  • Depth of response in patients with locally advanced pancreatic cancer treated with first-line chemotherapy: A supplementary analysis of JCOG1407. International journal

    Taro Shibuki, Masafumi Ikeda, Masayuki Yokoyama, Yusuke Sano, Junji Furuse, Satoshi Kobayashi, Akihiro Ohba, Akiko Todaka, Yoshiki Horie, Kazuhiko Shioji, Masashi Kanai, Tomohiro Nishina, Yusuke Kumamoto, Nao Fujimori, Akio Katanuma, Yukiko Takayama, Hidetaka Tsumura, Haruo Miwa, Masato Ozaka, Makoto Ueno

    Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.]   2025.2

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    BACKGROUND/OBJECTIVES: Depth of response (DpR; maximum % reduction from baseline in sum of the target lesion diameters) has demonstrated potential in predicting prognosis in several malignancies. However, its role in locally advanced pancreatic cancer (LAPC) is still unclear. In JCOG1407, modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP) exhibited comparable efficacy for LAPC. In this exploratory analysis using the data of JCOG1407, we focused on the association between DpR and prognosis. METHODS: DpR was classified into three groups at the tertile point and patients' backgrounds and survival were compared. The impact of DpR on survival outcomes was evaluated using the multivariable Cox proportional hazard model. RESULTS: Of the 126 patients enrolled in JCOG1407, 109 patients were included, categorized into three DpR groups: T1 (<-37.2 %), T2 (-37.2 to -13.6 %), and T3 (>-13.6 %). The median DpR was significantly greater in the GnP arm than in the mFOLFIRINOX arm (-28.9 vs. -22.7 %, P = 0.041). Median duration of response tended to be shorter in the GnP arm than in the mFOLFIRINOX arm, although the difference was not significant (5.3 vs. 8.2 months, P = 0.132). Greater DpR (T1) had a significantly larger impact on better progression-free survival (PFS) and overall survival (OS) than T3, with the hazard ratio of 0.469 (95 % confidence interval [CI] 0.268-0.821, P = 0.008), and 0.398 (95 % CI 0.217-0.728, P = 0.003), respectively. CONCLUSIONS: mFOLFIRINOX and GnP had similar OS, it is noteworthy that the regimens exhibited differences in DpR, with GnP leading to greater DpR. Greater DpR are associated with improved survival in patients with LAPC.

    DOI: 10.1016/j.pan.2025.02.005

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  • Diagnostic Accuracy of Detective Flow Imaging Endoscopic Ultrasonography for Evaluating Blood Flow Within Mural Nodules of Intraductal Papillary Mucinous Neoplasms

    Kazuki Endo, Haruo Miwa, Kazuya Sugimori, Kozue Shibasaki, Shoichiro Yonei, Yugo Ishino, Shotaro Tsunoda, Hayato Yoshimura, Akihiro Funaoka, Hiromi Tsuchiya, Ritsuko Oishi, Yuichi Suzuki, Satoshi Komiyama, Takashi Kaneko, Manabu Morimoto, Kazushi Numata, Shin Maeda

    Diagnostics   2025.1

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    DOI: 10.3390/diagnostics15020196

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  • Assessment of heterogeneity according to hospital or medical experience factors in outcomes of chemotherapy for advanced biliary tract cancer: a post-hoc analysis of JCOG1113. International journal

    Koh Fukushi, Hiroshi Imaoka, Masafumi Ikeda, Junki Mizusawa, Chigusa Morizane, Takuji Okusaka, Satoshi Kobayashi, Naoki Sasahira, Satoshi Shimizu, Kentaro Yamazaki, Naohiro Okano, Haruo Miwa, Kazuo Hara, Sohei Satoi, Keiji Sano, Kenji Sakai, Rie Sugimoto, Kazuyoshi Nakamura, Takeshi Terashima, Masato Ozaka, Makoto Ueno

    Japanese journal of clinical oncology   2025.1

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    BACKGROUND: JCOG1113 is a randomized phase III trial that showed non-inferiority of gemcitabine plus S-1 to gemcitabine plus cisplatin in patients with advanced biliary tract cancer. Assessment of inter-institutional heterogeneity in chemotherapy contributes to confirm generalizability and reliability of the study itself. However, there have been no studies conducted to assess the heterogeneity among participating centers in randomized phase III trials for biliary tract cancer. METHODS: The objective of this post-hoc analysis was to assess the inter-institutional heterogeneity in the overall survival and progression-free survival of patients with advanced biliary tract cancer treated with first-line chemotherapy in the JCOG1113 trial. The heterogeneity in the overall survival and progression-free survival was assessed according to three factors: hospital volume, experience in medical oncology and experience in biliary intervention. A total of 300 advanced biliary tract cancer patients were analyzed. There were no statistically significant trends observed between hospital volume, experience in medical oncology, or experience in biliary intervention and overall survival (hospital volume: adjusted trend P value = 0.6796; experience in medical oncology: adjusted trend P value = 0.4092; experience in biliary intervention: adjusted trend P value = 0.6112). Similarly, no statistically significant trends were observed between these factors and progression-free survival (hospital volume: adjusted trend P value = 0.3000; experience in medical oncology: adjusted trend P value = 0.1108; experience in biliary intervention: adjusted trend P value = 0.2898). CONCLUSIONS: This study revealed no inter-institutional heterogeneity in the overall survival and progression-free survival in the JCOG1113 study population of advanced biliary tract cancer patients.

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  • Safety and Efficacy of a 6‐Month Placement of a Fully Covered Self‐Expanding Metallic Stent for Refractory Benign Biliary Stricture: A Multicenter Prospective Study

    Tomohisa Iwai, Mitsuhiro Kida, Kazuya Sugimori, Hiroaki Shigoka, Takaaki Matsumoto, Masashi Ijima, Haruo Miwa, Kosuke Okuwaki, Masafumi Watanabe, Kai Adachi, Akihiro Tamaki, Taro Hanaoka, Junro Ishizaki, Chika Kusano

    JGH Open   2025.1

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    DOI: 10.1002/jgh3.70103

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  • The stability of a novel 0.035-inch guidewire facilitates endoscopic ultrasound-guided hepaticoduodenostomy. International journal

    Ritsuko Oishi, Haruo Miwa, Kazuki Endo, Hiromi Tsuchiya, Akihiro Funaoka, Yuichi Suzuki, Shin Maeda

    Endoscopy   56 ( S 01 )   E1078-E1079   2024.12

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    DOI: 10.1055/a-2468-6484

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  • Antegrade metallic stent placement using a slim cholangioscope for malignant afferent loop obstruction. International journal

    Haruo Miwa, Ritsuko Oishi, Kazuki Endo, Hiromi Tsuchiya, Akihiro Funaoka, Yuichi Suzuki, Shin Maeda

    Endoscopy   56 ( S 01 )   E774-E775   2024.12

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    DOI: 10.1055/a-2387-4238

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  • Bipolar forceps coagulation for endoscopic papillectomy-related bleeding

    Kozue Shibasaki, Haruo Miwa, Yuichi Suzuki, Kazuki Endo, Ritsuko Oishi, Hiromi Tsuchiya, Shin Maeda

    Endoscopy   2024.12

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    DOI: 10.1055/a-2440-6432

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  • Novel self-expandable metallic stent with dumbbell-shape and spiral outer cover for malignant distal biliary obstruction. International journal

    Haruo Miwa, Yugo Ishino, Shotaro Tsunoda, Kazuki Endo, Ritsuko Oishi, Yuichi Suzuki, Shin Maeda

    Endoscopy   56 ( S 01 )   E849-E850   2024.12

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    DOI: 10.1055/a-2420-7965

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  • Endoscopic ultrasound-guided salvage technique for pancreatic duct injury during endoscopic papillectomy. International journal

    Haruo Miwa, Kazuki Endo, Ritsuko Oishi, Yugo Ishino, Shotaro Tsunoda, Yuichi Suzuki, Shin Maeda

    Endoscopy   56 ( S 01 )   E856-E857   2024.12

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    DOI: 10.1055/a-2418-3257

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  • Endoscopic ultrasound-guided gallbladder drainage using a forward-viewing echoendoscope after Billroth II gastrectomy

    Yuichiro Tozuka, Kazuya Sugimori, Haruo Miwa, Takashi Kaneko, Makoto Ueno, Junji Furuse, Shin Maeda

    Endoscopy   2024.12

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    DOI: 10.1055/a-2271-4124

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  • Peroral pancreatoscopy without a guidewire for intraductal papillary mucinous neoplasm. International journal

    Haruo Miwa, Kazuki Endo, Shotaro Tsunoda, Ritsuko Oishi, Yuichi Suzuki, Hiromi Tsuchiya, Shin Maeda

    Endoscopy   56 ( S 01 )   E797-E798   2024.12

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    DOI: 10.1055/a-2408-8685

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  • Curved puncture technique using a flexible stainless-steel needle in endoscopic ultrasound-guided hepaticogastrostomy. International journal

    Haruo Miwa, Yuichi Suzuki, Shotaro Tsunoda, Kazuki Endo, Ritsuko Oishi, Hiromi Tsuchiya, Shin Maeda

    Endoscopy   56 ( S 01 )   E1082-E1083   2024.12

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  • Feasibility of Peroral Cholangioscopy in the Initial Endoscopic Retrograde Cholangiopancreatography for Malignant Biliary Strictures

    Yuichi Suzuki, Tomohiro Ishii, Haruo Miwa, Takeshi Sato, Yoshihiro Goda, Kuniyasu Irie, Kazuya Sugimori, Shin Maeda

    Diagnostics   2024.11

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    DOI: 10.3390/diagnostics14222589

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  • Feasibility of Peroral Cholangioscopy in the Initial Endoscopic Retrograde Cholangiopancreatography for Malignant Biliary Strictures. International journal

    Yuichi Suzuki, Tomohiro Ishii, Haruo Miwa, Takeshi Sato, Yoshihiro Goda, Kuniyasu Irie, Kazuya Sugimori, Shin Maeda

    Diagnostics (Basel, Switzerland)   14 ( 22 )   2024.11

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    Background: Peroral cholangioscopy (POCS) is valuable for assessing malignant biliary strictures; however, biliary drainage prior to POCS often hinders accurate diagnosis. Objectives: This retrospective study aimed to investigate the feasibility of POCS using a newly developed cholangioscope, CHF-B290, during initial endoscopic retrograde cholangiopancreatography (ERCP) for malignant biliary strictures. Methods: This multicenter retrospective study included patients who underwent initial ERCP for malignant biliary strictures at two institutions between January 2018 and March 2022. Patients who underwent initial ERCP with POCS were classified into the POCS group, and those without POCS were classified into the non-POCS group. To prevent post-POCS cholangitis, the original irrigation system for CHF-B290 was used in all POCS examinations. The primary endpoint was the rate of post-ERCP biliary infections, and the secondary endpoints were other ERCP-related complications, including pancreatitis, bleeding, and perforation. Results: Overall, 53 and 94 patients were included in the POCS and non-POCS groups, respectively. For the primary endpoint, the rate of post-ERCP biliary infection was not significantly different between the two groups (1.9% vs. 5.3%, p = 0.42). For the secondary endpoints, no significant differences were observed in the rates of post-ERCP pancreatitis (5.7% vs. 6.4%, p = 1.00) and other ERCP-related complications. The overall complication rate was 9.4% in the POCS group and 13% in the non-POCS group (p = 0.60). Conclusions: POCS during the initial ERCP for malignant biliary strictures is feasible.

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  • Enhancing deep-seated hepatocellular carcinoma detection: assessing the added value of high mechanical index setting in sonazoid-based contrast-enhanced ultrasound during post-vascular phase.

    Ying Zhang, Kazushi Numata, Hiromi Nihonmatsu, Akihiro Funaoka, Haruo Miwa, Ritsuko Oishi, Akito Nozaki, Shin Maeda

    Journal of medical ultrasonics (2001)   2024.11

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    PURPOSE: This retrospective study aimed to investigate the role of an additional high mechanical index (MI) setting scan during the post-vascular phase (PVP) in detecting deep-seated hepatocellular carcinoma (HCC) lesions. METHODS: A total of 805 confirmed HCCs, which underwent Sonazoid-based contrast-enhanced ultrasound (CEUS) between January 2014 and October 2021, were included. Low MI scan was initially employed for lesion detection during the PVP, followed by high MI scan. Propensity score matching (PSM) was utilized to address confounding variables. RESULTS: Of the 805 study lesions, 668 were detected as perfusion defects at the initial low MI setting, while 137 remained undetected. Among these 137 undetected lesions, 77 were identified at the subsequent high MI setting, whereas 60 remained undetected. Lesions that were larger (18.69 ± 11.27 mm vs. 16.55 ± 7.42 mm, p = 0.006), more superficial (6.06 ± 2.41 cm vs. 7.40 ± 2.74 cm, p < 0.001), and hypoechoic (482/668 vs. 62/137, p < 0.001) were detectable at the initial low MI setting. Male patients benefited more from the additional high MI scan (63/97 vs. 14/40, p < 0.001). Lesions identified with additional high MI were larger (18.30 ± 8.76 mm vs. 14.30 ± 4.34 mm, p < 0.001) and deeper than undetected ones (8.48 ± 2.48 cm vs. 6.02 ± 2.43 cm, p < 0.001). After PSM, depth was shown to be an independent predictor in multivariate analysis (odds ratio: 1.557, 95% confidence interval: 1.249-1.941). The depth cutoff was 7.75 cm, with a sensitivity of 0.681, specificity of 0.851, and area under the curve of 0.774. CONCLUSIONS: The additional high MI setting scan during the PVP of Sonazoid-based CEUS leads to enhanced detection of deep-seated HCCs.

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  • Influence of major hepatectomy on gemcitabine-based chemotherapy for recurrent biliary tract cancer after surgery: a subgroup analysis of JCOG1113.

    Tatsuya Okuno, Chigusa Morizane, Junki Mizusawa, Hiroaki Yanagimoto, Satoshi Kobayashi, Hiroshi Imaoka, Takeshi Terashima, Hisato Kawakami, Yusuke Sano, Takuji Okusaka, Masafumi Ikeda, Masato Ozaka, Haruo Miwa, Akiko Todaka, Satoshi Shimizu, Nobumasa Mizuno, Mitsugu Sekimoto, Keiji Sano, Kazutoshi Tobimatsu, Akio Katanuma, Kunihito Gotoh, Hironori Yamaguchi, Hiroshi Ishii, Junji Furuse, Makoto Ueno

    International journal of clinical oncology   2024.10

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    BACKGROUND: Major hepatectomy (MH) can increase the risk of adverse events (AEs) owing to impaired drug metabolism due to decreased liver volume and surgical injury. Thus, we performed this subgroup analysis using data from JCOG1113, a phase III trial comparing gemcitabine plus S-1 (GS) and gemcitabine plus cisplatin (GC) in patients with advanced and recurrent biliary tract cancer (BTC), to evaluate the effect of MH on the safety and efficacy of GC and GS regimens in patients with recurrent BTC. METHODS: Of the 354 patients with advanced BTC enrolled in JCOG1113, 76 patients with postoperative recurrence (30 in the MH group and 46 in the non-MH group) were analyzed. RESULTS: Grade ≥ 3 platelet count decreased in both arms was more frequent in the MH group than in non-MH group (GC, 0.0 vs. 17.6%; GS, 3.9 vs. 15.4%). However, in the MH group, the white blood cell decreased (GC, 55.0 vs. 38.5%; GS, 23.1 vs. 7.7%) and anemia (GC, 15.0 vs. 11.8%; GS, 23.1 vs. 7.7%) were less common than in the non-MH group. The MH and non-MH groups showed no significant difference in overall survival (OS) in both GC [median OS, 23.0 in MH vs. 16.9 months in non-MH (hazard ratio, 0.857; 95% CI 0.387-1.899)], and GS [median OS, 21.5 vs. 14.9 months (hazard ratio, 0.670; 95% CI 0.310-1.447)] arms. CONCLUSIONS: The safety and efficacy of gemcitabine-based chemotherapy were comparable between patients who underwent MH and those who underwent other surgeries.

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  • 5-Fluorouracil metabolic pathway genes predict recurrence risk following adjuvant S-1 therapy: Results of an ancillary analysis from a phase III trial of resected biliary tract cancer (JCOG1202A1).

    Shuichi Mitsunaga, Masafumi Ikeda, Shogo Nomura, Chigusa Morizane, Akiko Todaka, Naoto Yamamoto, Ken Kamata, Hiroo Yanagibashi, Nobumasa Mizuno, Yasuyuki Kawamoto, Kunihito Gotoh, Hirofumi Shirakawa, Naohiro Okano, Tatsuya Nomura, Kazunari Tanaka, Amane Takahashi, Shintaro Yagi, Koji Ohta, Yukiko Takayama, Haruo Miwa, Hiroaki Nagano, Yasushi Kojima, Terumasa Hisano, Munenori Tahara, Yasunaru Sakuma, Hiroyuki Arai, Ikuo Nakamura, Hiroshi Katayama, Masaru Konishi, Makoto Ueno

    Journal of hepato-biliary-pancreatic sciences   2024.9

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    BACKGROUND: S-1, an oral fluoropyrimidine derivative, is standard adjuvant therapy for resected biliary tract cancer (BTC), based on the results of the JCOG1202, a phase III trial evaluating the survival benefit with adjuvant S-1 following curative resection for BTC compared to surgery alone. This multicenter ancillary study of the JCOG1202 aimed to evaluate the prognostic impact of the 5-fluorouracil (5-FU) metabolic pathway genes including thymidine phosphorylase (TP) and dihydropyrimidine dehydrogenase (DPD). METHODS: The 5-FU metabolic pathway genes were measured in tumor cells from formalin-fixed paraffin-embedded resected specimens from 183 patients (surgery alone: n = 94; adjuvant S-1: n = 89). We randomly divided them into training (n = 96) and validation sets (n = 87) for evaluating the interaction between gene levels and RFS benefits in the treatment arm. RESULTS: RFS benefits of adjuvant S-1 were observed in the low DPD (HR = 0.440 and 0.748, respectively in the training and validation sets) and the low TP groups (HR = 0.709 and 0.602, respectively). Clinicopathological characteristics were well balanced between low and high DPD populations. More advanced stage tumors were observed in high TP populations as compared to those in low TP populations (p = .0332). CONCLUSION: The results suggest the RFS benefit of adjuvant S-1 in resected BTC patients with low DPD and low TP gene expressions.

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  • Laser lithotripsy with balloon enteroscopy-assisted peroral cholangioscopy for a large common bile duct stone after Billroth II gastrectomy. International journal

    Haruo Miwa, Kazuya Sugimori, Shin Maeda

    Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society   2024.7

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    DOI: 10.1111/den.14888

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  • Transarterial and Transvenous Approach for the Embolization of Arteriovenous Fistula between the Hepatic Arteries and Inferior Vena Cava Associated with Liver Abscess Due to Cholangitis.

    Ryo Aoki, Yusuke Kobayashi, Kento Nakajima, Hiroyuki Kamide, Haruo Miwa, Hiromi Tsuchiya, Ritsuko Oishi, Akihiro Inoue, Sayo Irie, Yuka Misumi, Harumi Mochizuki, Shigeru Magami, Kazuya Sugimori, Zenjiro Sekikawa, Daisuke Utsunomiya

    Interventional radiology (Higashimatsuyama-shi (Japan)   9 ( 2 )   69 - 73   2024.7

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    An 87-year-old woman was hospitalized for liver abscesses and cholangitis due to common bile duct stones. She developed worsening anemia and abdominal pain. Contrast-enhanced computed tomography revealed an intrahepatic pseudoaneurysm and an arteriovenous fistula between the hepatic arteries and inferior vena cava. The initial endovascular treatment was transarterial embolization. The pseudoaneurysm was embolized with an N-butyl-2-cyanoacrylate mixture, and the inflow arteries of the arteriovenous fistula were embolized with microcoils. However, the residual perfusion of the arteriovenous fistula remained. A second endovascular treatment was performed using the transarterial and transvenous approaches. The inflow arteries were embolized using microcoils and gelatin sponges and the dominant outflow vein was embolized using microcoils, resulting in the disappearance of the perfusion in the arteriovenous fistula.

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  • Clinical course of small gastric subepithelial lesion less than 20 mm diagnosed by endoscopic ultrasound‐guided fine‐needle aspiration

    Ryosuke Kobayashi, Kingo Hirasawa, Yuichiro Ozeki, Atsushi Sawada, Masafumi Nishio, Chiko Sato, Haruo Miwa, Takashi Kaneko, Kazuya Sugimori, Shin Maeda

    Journal of Gastroenterology and Hepatology   2024.7

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    DOI: 10.1111/jgh.16534

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  • Current status of the cost burden of first-line systemic treatment for patients with advanced hepatocellular carcinoma in Japan, 2021-22. International journal

    Hiroshi Imaoka, Keita Sasaki, Ryunosuke Machida, Hiroaki Nagano, Sohei Satoi, Masafumi Ikeda, Satoshi Kobayashi, Taro Yamashita, Takuji Okusaka, Akio Ido, Etsuro Hatano, Haruo Miwa, Masaki Ueno, Kazuhiko Nakao, Satoshi Shimizu, Hidekazu Kuramochi, Ryotaro Sakamori, Hidetaka Tsumura, Naohiro Okano, Kazuhiko Shioji, Hirofumi Shirakawa, Noriyuki Akutsu, Kunihiro Tsuji, Hiroshi Ishii, Kumiko Umemoto, Akinori Asagi, Makoto Ueno

    Japanese journal of clinical oncology   2024.6

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    BACKGROUND: Although recent advances in systemic therapies for hepatocellular carcinoma (HCC) have led to prolonged patient survival, the high costs of the drugs place a heavy burden on both patients and society. The objectives of this study were to examine the treatment regimens used as first-line systemic treatment for patients with advanced HCC in Japan and to estimate the treatment costs per regimen. METHODS: For this study, we aggregated the data of patients who had received first-line systemic treatment for advanced HCC between July 2021 and June 2022. The treatment cost per month of each regimen was estimated based on standard usage, assuming an average weight of 60 kg for male patients. The data were categorized by the treatment regimen, and the treatments were categorized based on the cost into very high-cost (≥1 000 000 Japanese yen [JPY]/month), high-cost (≥500 000 JPY/month) and other (<500 000 JPY/month) treatments. RESULTS: Of the total of 552 patients from 24 institutions whose data were analyzed in this study, 439 (79.5%) received atezolizumab plus bevacizumab, 98 (17.8%) received lenvatinib and 15 (2.7%) received sorafenib as the first-line treatment. The treatment cost per month for each of the above regimens was as follows: atezolizumab plus bevacizumab, 1 176 284 JPY; lenvatinib, 362 295 JPY and sorafenib, 571 644 JPY. In total, 82.2% of patients received high-cost regimens, and the majority of these patients received a very high-cost regimen of atezolizumab plus bevacizumab. CONCLUSIONS: Advances in systemic therapies for HCC have led to prolonged patient survival. However, the treatment costs are also increasing, imposing a burden on both the patients and society.

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  • The usefulness of texture and color enhancement imaging to identify the minor papilla orifice

    Yoshihiro Goda, Kuniyasu Irie, Hideyuki Anan, Yuichi Suzuki, Aya Ikeda, Ryosuke Ikeda, Hiroaki Kaneko, Soichiro Sue, Haruo Miwa, Shin Maeda

    DEN Open   2024.4

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    DOI: 10.1002/deo2.358

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  • A case of advanced biliary tract cancer with EGFR amplification that responded to Necitumumab and post-treatment resistance changes detected by liquid biopsy

    Makoto Sugimori, Masaki Nishimura, Kazuya Sugimori, Sho Tsuyuki, Akane Hirotani, Haruo Miwa, Takashi Kaneko, Haruka Hirose, Yoshiaki Inayama, Akito Nozaki, Kazushi Numata, Chikara Kunisaki, Shin Maeda

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  • Novel 8‐wire basket catheter is useful for endoscopic removal of common bile duct stones up to 10 mm: A multicenter prospective study

    Takashi Kaneko, Tomohiro Ishii, Jun Hamanaka, Yoshihiro Goda, Kuniyasu Irie, Nobutaka Doba, Yosuke Kunishi, Haruo Miwa, Kazuya Sugimori, Shin Maeda

    Journal of Hepato-Biliary-Pancreatic Sciences   2024.3

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  • Protocol for a Multi-Center Confirmatory Trial to Evaluate the Differential Diagnostic Performance of Contrast-Enhanced Ultrasonography Using Perflubutane in Patients with a Pancreatic Mass: A Multicenter Prospective Study. International journal

    Yasunobu Yamashita, Toshio Shimokawa, Reiko Ashida, Yoshiki Hirooka, Takuji Iwashita, Hironari Kato, Toshifumi Kin, Atsushi Masamune, Haruo Miwa, Eizaburo Ohno, Hideyuki Shiomi, Atsushi Sofuni, Mamoru Takenaka, Masayuki Kitano

    Diagnostics (Basel, Switzerland)   14 ( 2 )   2024.1

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    For pancreatic masses, an evaluation of their vascularity using contrast-enhanced ultrasonography can help improve their characterization. This study was designed to evaluate the utility and safety of contrast-enhanced transabdominal ultrasonography (CE-TUS) and endoscopic ultrasonography (CE-EUS) in the diagnosis of pancreatic masses including solid or cystic masses. This multi-center comparative open-label superiority study is designed to compare Plain (P)-TUS/EUS alone with P-TUS/P-EUS plus CE-TUS/CE-EUS. Three hundred and one patients with a total of 232 solid pancreatic masses and 69 cystic masses were prospectively enrolled. The primary endpoints are to compare the diagnostic accuracy between P-TUS/P-EUS alone and P-TUS/P-EUS plus CE-TUS/CE-EUS for both the TUS and EUS of solid pancreatic masses, and to compare the diagnostic accuracy between P-EUS alone and P-EUS plus CE-EUS in cystic pancreatic masses. The secondary endpoints are to compare the diagnostic sensitivity and specificity of P-TUS/P-EUS alone and P-TUS/P-EUS plus CE-TUS/CE-EUS for pancreatic solid/cystic masses, and the accuracy of P-TUS alone and P-TUS plus CE-TUS for pancreatic cystic masses. Other secondary endpoints included comparing the diagnostic sensitivity, specificity, and accuracy of CE-TUS, CE-EUS and CE-computed tomography (CT) for solid/cystic pancreatic masses. The safety, degree of effective enhancement, and diagnostic confidence obtained with CE-TUS/CE-EUS will also be assessed.

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  • Usefulness of the two-devices-in-one-channel technique for difficult bile duct intubation in patients without periampullary diverticulum. International journal

    Takashi Kaneko, Kazuya Sugimori, Kazuki Endo, Masaki Nishimura, Yuichiro Tozuka, Haruo Miwa, Shin Maeda

    Endoscopy   55 ( S 01 )   E76-E77   2023.12

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  • Effect of systemic inflammatory response on induction chemotherapy followed by chemoradiotherapy for locally advanced pancreatic cancer: an exploratory subgroup analysis on systemic inflammatory response in JCOG1106 Reviewed International journal

    Nobumasa Mizuno, Tatsuya Ioka, Gakuto Ogawa, Satoaki Nakamura, Nobuyoshi Hiraoka, Yoshinori Ito, Hiroshi Katayama, Ryoji Takada, Satoshi Kobayashi, Masafumi Ikeda, Haruo Miwa, Naohiro Okano, Hidekazu Kuramochi, Mitsugu Sekimoto, Takuji Okusaka, Masato Ozaka, Akiko Todaka, Kunihito Gotoh, Kazutoshi Tobimatsu, Hironori Yamaguchi, Toshio Nakagohri, Shinya Kajiura, Kentaro Sudo, Keiya Okamura, Satoshi Shimizu, Hirofumi Shirakawa, Naoya Kato, Keiji Sano, Tomohisa Iwai, Nao Fujimori, Makoto Ueno, Hiroshi Ishii, Junji Furuse

    Japanese Journal of Clinical Oncology   53 ( 8 )   704 - 713   2023.5

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    Abstract

    Objective

    JCOG1106, a randomized phase II trial conducted to compare chemoradiotherapy (S-1 concurrent radiotherapy) with (Arm B) or without (Arm A) induction chemotherapy using gemcitabine in patients with locally advanced pancreatic cancer, showed a more favorable long-term survival in Arm A. This study was aimed at exploring whether some subgroups classified by the systemic inflammatory response might derive greater benefit from either treatment.

    Methods

    All subjects eligible for JCOG1106 were included in this analysis (n = 51/49 in Arm A/B). This exploratory subgroup analysis was performed by Cox regression analysis to investigate the impact of the systemic inflammatory response, as assessed based on the serum C-reactive protein, serum albumin (albumin), Glasgow Prognostic Score and derived neutrophil–lymphocyte ratio, at the baseline on overall survival. P values &amp;lt;0.1 for the interaction were regarded as denoting significant association.

    Results

    Glasgow prognostic score showed significant treatment interactions for overall survival. Hazard ratios of Arm B to Arm A were 1.35 (95% confidence interval, 0.82–2.23) in the Glasgow Prognostic Score 0 (C-reactive protein ≤10 mg/L and albumin ≥35 g/L) (n = 44/34 in Arm A/B) and 0.59 (95% confidence interval, 0.24–1.50) in the Glasgow Prognostic Score 1/2 (C-reactive protein &amp;gt;10 mg/L and/or albumin &amp;lt;35 g/L) (n = 7/15) (P-interaction = 0.06). C-reactive protein alone and albumin alone also showed significant treatment interactions for overall survival.

    Conclusions

    Survival benefits of induction chemotherapy in chemoradiotherapy for locally advanced pancreatic cancer were observed in patients with elevated Glasgow Prognostic Score, high C-reactive protein and low albumin. These results suggest that systemic inflammatory response might be considered to apply induction chemotherapy preceding chemoradiotherapy.

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  • A randomised phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer (JCOG1407). International journal

    Masato Ozaka, Kohei Nakachi, Satoshi Kobayashi, Akihiro Ohba, Hiroshi Imaoka, Takeshi Terashima, Hiroshi Ishii, Junki Mizusawa, Hiroshi Katayama, Tomoko Kataoka, Takuji Okusaka, Masafumi Ikeda, Naoki Sasahira, Haruo Miwa, Eishiro Mizukoshi, Naohiro Okano, Nobumasa Mizuno, Tomohisa Yamamoto, Yoshito Komatsu, Akiko Todaka, Ken Kamata, Masayuki Furukawa, Nao Fujimori, Akio Katanuma, Yukiko Takayama, Hidetaka Tsumura, Haruhiko Fukuda, Makoto Ueno, Junji Furuse

    European journal of cancer (Oxford, England : 1990)   181   135 - 144   2023.3

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    AIM: We compared the efficacy of modified 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX) with that of gemcitabine plus nab-paclitaxel (GnP) for locally advanced pancreatic cancer (LAPC). METHODS: Patients with untreated LAPC were randomly assigned (1:1) to receive mFOLFIRINOX or GnP. One-year overall survival (OS) was the primary endpoint. The major secondary end-points included progression-free survival (PFS), response rate (RR), carbohydrate antigen 19-9 (CA19-9) response, and adverse events. The sample size was 124 patients to select a more effective regimen with a minimum probability of 0.85 and to examine the null hypothesis of the 1-year OS <53%. RESULTS: Of the 126 patients enrolled from 29 institutions, 125 were deemed eligible. The 1-year OS was 77.4% (95% CI, 64.9-86.0) and 82.5% (95% CI, 70.7-89.9) in the mFOLFIRINOX and GnP arms, respectively. The median PFS was 11.2 (95% CI, 9.9-15.9) and 9.4 months (95% CI, 7.4-12.8) in the mFOLFIRINOX and GnP arms, respectively. The RR and CA19-9 response rate were 30.9% (95% CI, 19.1-44.8) and 57.1% (95% CI, 41.0-72.3) and 42.1% (95% CI 29.1-55.9) and 85.0% (95% CI, 70.2-94.3) in the mFOLFIRINOX and GnP arms, respectively. Grade 3-4 diarrhoea and anorexia were predominant in the mFOLFIRINOX arm. CONCLUSION: GnP was considered the candidate for a subsequent phase III trial because of its better RR, CA19-9 response, and mild gastrointestinal toxicities. Both regimens displayed higher efficacy in the 1-year survival than in the historical data of gemcitabine monotherapy.

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  • Efficacy of chemotherapy for patients with metastatic or recurrent pancreatic adenosquamous carcinoma: A multicenter retrospective analysis. International journal

    Yukio Yoshida, Satoshi Kobayashi, Makoto Ueno, Chigusa Morizane, Kunihiro Tsuji, Yuta Maruki, Keita Mori, Kazuo Watanabe, Akihiro Ohba, Mitsuhiro Furuta, Akiko Todaka, Akiko Tsujimoto, Masato Ozaka, Naohiro Okano, Kei Yane, Kumiko Umemoto, Yasuyuki Kawamoto, Takeshi Terashima, Hidetaka Tsumura, Keitaro Doi, Kazuhiko Shioji, Akinori Asagi, Yasushi Kojima, Eiichiro Suzuki, Reishi Toshiyama, Masayuki Furukawa, Atsushi Naganuma, Rei Suzuki, Haruo Miwa, Masafumi Ikeda, Junji Furuse

    Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.]   22 ( 8 )   1159 - 1166   2022.12

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    BACKGROUND/OBJECTIVES: Pancreatic adenosquamous carcinoma (PASC) is a rare variant of pancreatic ductal adenocarcinoma (PDAC). The usual treatment for metastatic or recurrent PASC is systemic chemotherapy in accordance with the PDAC treatment strategy. This study aimed to investigate the efficacy of chemotherapy, especially the benefit of recent combination therapies, in patients with metastatic or recurrent PASC. METHODS: We conducted a multicenter retrospective analysis of 116 patients with metastatic or recurrent PASC treated with first-line chemotherapy between April 2001 and December 2017 at 24 Japanese institutions. RESULTS: Combination chemotherapies included gemcitabine + nab-paclitaxel (GnP, n = 28), fluorouracil/leucovorin + irinotecan + oxaliplatin (FFX, n = 10), gemcitabine + S-1 (GS, n = 10), and others (n = 9). Monotherapies included gemcitabine (n = 51) and S-1 (n = 8). The median overall survival (OS) was 6.5, 7.3, and 4.3 months for the whole cohort, the combination therapy group, and the monotherapy group, respectively. Multivariate analysis indicated that combination therapy showed a better trend in OS than monotherapy (hazard ratio = 0.68; 95% confidence interval, 0.38-1.20). GnP or FFX were selected in 58.7% of patients after FFX was approved in Japan, and revealed a median OS, median progression-free survival, and objective response rate of 7.3 months, 2.8 months, and 26.9% in GnP and 7.2 months, 2.3 months, and 20.0% in FFX respectively. CONCLUSIONS: This study suggests that combination therapy may be more effective than monotherapy. GnP and FFX showed similar and clinically meaningful efficacy for patients with metastatic or recurrent PASC.

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  • Comparing the Efficacy and Safety of Gemcitabine plus Nab-Paclitaxel versus Gemcitabine Alone in Older Adults with Unresectable Pancreatic Cancer. International journal

    Satoshi Kobayashi, Motoko Suzuki, Makoto Ueno, Yuta Maruki, Naohiro Okano, Akiko Todaka, Masato Ozaka, Kunihiro Tsuji, Kazuhiko Shioji, Keitaro Doi, Yasushi Kojima, Hidetaka Tsumura, Kazunari Tanaka, Hajime Higuchi, Ken Kawabe, Hiroshi Imaoka, Tatsuya Yamashita, Haruo Miwa, Hiroaki Nagano, Shiho Arima, Hideyuki Hayashi, Atsushi Naganuma, Hironori Yamaguchi, Terumasa Hisano, Kumiko Umemoto, Shuji Ishii, Koji Nakashima, Rei Suzuki, Yohei Kitano, Toshihiro Misumi, Junji Furuse, Hiroshi Ishii

    The oncologist   27 ( 10 )   e774-e782   2022.10

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    BACKGROUND: Gemcitabine plus nab-paclitaxel (GnP) has been a standard treatment for unresectable pancreatic cancer (uPC); however, the current treatment status and usefulness in older adults with uPC remain unclear. Therefore, we aimed to investigate the patient background and compare the efficacy and safety of GnP versus other treatments in older adults with uPC. PATIENTS AND METHODS: In this prospective observational study, we enrolled 233 eligible patients aged ≥76 years with pathologically proven, clinically uPC, and no history of chemotherapy from 55 Japanese centers during September 2018-September 2019. The main endpoints were overall survival (OS), progression-free survival (PFS), and safety. Geriatric assessments were performed upon registration and after 3 months. To adjust for confounders, we conducted propensity score-matched analyses. RESULTS: GnP, gemcitabine alone (Gem), best supportive care, and other therapies were administered to 116, 72, 16, and 29 patients, respectively. In the propensity score-matched analysis, 42 patients each were selected from the GnP and Gem groups. The median OS was longer in the GnP group than in the Gem group (12.2 vs. 9.4 months; hazard ratio [HR], 0.65; 95% CI, 0.37-1.13). The median PFS was significantly longer in the GnP group than in the Gem group (9.2 vs. 3.7 months; HR, 0.38; 95% CI, 0.23-0.64). The incidence of severe adverse events was higher with GnP than with Gem; however, the difference was not significant. CONCLUSION: GnP is more efficacious than Gem in patients aged ≥76 years with uPC despite demonstrating a higher incidence of severe adverse events.

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  • Case reports: chemoradiotherapy for locally advanced neuroendocrine carcinoma of the gallbladder.

    Yuma Takeda, Noritoshi Kobayashi, Takaomi Kessoku, Naoki Okubo, Akihiro Suzuki, Motohiko Tokuhisa, Haruo Miwa, Naoko Udaka, Yasushi Ichikawa

    Clinical journal of gastroenterology   15 ( 4 )   803 - 808   2022.8

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    Neuroendocrine carcinoma (NEC) is a rare subtype of malignant gallbladder tumor. Although surgical resection is the only potentially curative therapy for gallbladder NEC, most cases are surgically unresectable because of advanced stage disease and/or biologically aggressive behavior. The standard palliative treatment for malignant gallbladder tumors is chemotherapy; however, the efficacy of chemoradiotherapy in the treatment of gallbladder tumors is controversial. Here, we report a case of gallbladder NEC that showed a durable response to chemoradiotherapy. A 68-year-old Japanese man presented with a huge gallbladder tumor with liver and duodenal invasion. Pathological findings revealed poorly differentiated NEC of the gallbladder. After seven cycles of chemotherapy comprising cisplatin and irinotecan, computed tomography (CT) revealed remarkable tumor shrinkage, but an enlarged portal lymph node. The patient was treated with 50.4 Gy in 28 fractions with two cycles of cisplatin and etoposide. After chemoradiotherapy, the enlarged lymph node also decreased in size. Maximum standardized uptake value of fluorodeoxyglucose-positron emission tomography/CT(FDG-PET/CT) changed from 8.2 to physiological accumulation. We defined this condition as a complete response on both enhanced CT and FDG-PET/CT; therefore, we did not perform systemic treatment and only observed his condition. This patient remained healthy with no recurrence at 3 years after chemoradiotherapy.

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  • Endoscopic duodenal stent placement versus gastrojejunostomy for unresectable pancreatic cancer patients with duodenal stenosis before introduction of initial chemotherapy (GASPACHO study): a multicenter retrospective study. International journal

    Nobuaki Azemoto, Makoto Ueno, Hiroaki Yanagimoto, Nobumasa Mizuno, Yasuyuki Kawamoto, Yuta Maruki, Kazuo Watanabe, Rei Suzuki, Junichi Kaneko, Yuya Hisada, Hiroki Sato, Satoshi Kobayashi, Hideki Miyata, Masayuki Furukawa, Takuro Mizukami, Haruo Miwa, Yoshinori Ohno, Kunihiro Tsuji, Akiko Tsujimoto, Hiroaki Nagano, Hiroyuki Okuyama, Akinori Asagi, Naohiro Okano, Hiroshi Ishii, Chigusa Morizane, Masafumi Ikeda, Junji Furuse

    Japanese journal of clinical oncology   52 ( 2 )   134 - 142   2022.2

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    BACKGROUND: Endoscopic duodenal stent placement is an alternative technique to gastrojejunostomy for gastric outlet obstruction due to pancreatic cancer. We compared the efficacy of endoscopic duodenal stent placement with that of gastrojejunostomy for treating patients with pancreatic cancer who are candidates for intensive combination chemotherapies as the first line of treatment. METHODS: This retrospective observational study included 100 patients from 18 institutions in Japan. Inclusion criteria were as follows: (1) cytologically or histologically confirmed adenocarcinoma of the pancreas, (2) good performance status, (3) gastric outlet obstruction scoring system score of 0-1 and (4) no history of treatment for pancreatic cancer. RESULTS: There was no significant difference in the background characteristics of patients in the endoscopic duodenal stent placement (n = 57) and gastrojejunostomy (n = 43) groups. The median overall survival in the endoscopic duodenal stent placement and gastrojejunostomy groups was 5.9 and 6.0 months, respectively. Clinical success was achieved in 93 cases; the median time to food intake resumption was significantly shorter in the endoscopic duodenal stent placement group (median: 3 days, n = 54) than in the gastrojejunostomy group (median: 5 days, n = 43). Chemotherapy was introduced in 63% of the patients in both groups after endoscopic duodenal stent placement or gastrojejunostomy. Chemotherapy was started earlier in the endoscopic duodenal stent placement group (median: 14 days) than in the gastrojejunostomy (median: 32 days) group. CONCLUSIONS: Endoscopic duodenal stent placement showed similar or better clinical outcomes than gastrojejunostomy. Thus, it might be a promising option in patients with good performance status.

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  • Combination Therapy With Lenvatinib and Radiofrequency Ablation for Patients With Intermediate-Stage Hepatocellular Carcinoma Beyond Up-To-Seven Criteria and Child-Pugh Class A Liver function: A Pilot Study. International journal

    Feiqian Wang, Kazushi Numata, Satoshi Komiyama, Haruo Miwa, Kazuya Sugimori, Katsuaki Ogushi, Satoshi Moriya, Akito Nozaki, Makoto Chuma, Litao Ruan, Shin Maeda

    Frontiers in oncology   12   843680 - 843680   2022

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    BACKGROUND: The present study aimed to evaluate the efficacy and safety of combined lenvatinib (first-line systemic therapy) and radiofrequency ablation (RFA) therapy in patients with intermediate-stage hepatocellular carcinoma with beyond up-to-seven criteria and Child-Pugh Class A liver function (CP A B2-HCC). METHODS: Twenty-two patients with CP A B2-HCC were enrolled in the study. The patients had no history of systemic treatment. For the initial lenvatinib administration in this study, all of the patients had an adequate course of treatment (no less than two weeks) and were administered the recommended dose. Of them, 13 were treated by means of lenvatinib monotherapy (monotherapy group), while the 9 patients with no contraindication to RFA operation and who had consented to RFA received initial lenvatinib plus subsequent RFA (combination group). The clinical outcomes that were considered to evaluate the treatments included tumor response, prognosis (recurrence and survivals), and possible adverse events (serum liver enzymes and clinically visible complications). RESULTS: The combination group exhibited a higher object response rate (9/9, 100%) as best tumor response than the monotherapy group (10/13, 76.9%). Longer progression-free survival (PFS) (12.5 months) and overall survival (OS) (21.3) were demonstrated in the combination group than in the monotherapy group (PFS: 5.5 months; OS:17.1 months). The combination group achieved a higher PFS rate (1-year: 74.1%) and OS rate (2-year: 80%) than the monotherapy group (1-year PFS rate: 0%; 2-year OS rate: 25.6%; for PFS, p<0.001; for OS, p=0.022). The treatment strategy was the independent factor for PFS (HR: 18.215 for monotherapy, p =0.010), which was determined by Cox regression analysis, suggesting that a combination strategy may reduce tumor progression when compared to the use of lenvatinib alone. There were no statistically significant intergroup differences that were observed in terms of adverse events, with the exception of ALT elevation (p=0.007) in the combination group. CONCLUSION: Our newly proposed combination therapy may potentially be effective and safe for CP A B2-HCC beyond up-to-seven criteria. A larger scale, multicenter, prospective study is warranted to confirm our findings.

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  • Hemoperitoneum due to a ruptured right gastroepiploic artery following non-interventional endoscopic ultrasonography: a case report.

    Yuichiro Ozeki, Haruo Miwa, Kazuya Sugimori, Yoshihiro Goda, Akane Hirotani, Katsuyuki Sanga, Shun Tezuka, Kazushi Numata, Zenjiro Sekikawa, Shin Maeda

    Clinical journal of gastroenterology   14 ( 5 )   1371 - 1375   2021.10

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    Endoscopic ultrasonography has become a routine procedure in clinical practice and is widely accepted as a safe procedure. Previous studies have reported that severe bleeding rarely occurs even when performing fine-needle aspiration biopsy. Severe hemorrhage following non-interventional endoscopic ultrasonography has never been reported. We herein report a case of hemorrhagic shock due to hemoperitoneum caused by a ruptured right gastroepiploic artery consequent to a diagnostic endoscopic ultrasonography. The patient was administered two antithrombotic agents. An extensive diagnostic workup contributed to the correct diagnosis, which led to a successful treatment by transcatheter arterial embolization. Endoscopists should be aware of this rare, but potentially fatal, adverse event of endoscopic ultrasonography.

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  • A study on the inconsistency of arterial phase hypervascularity detection between contrast-enhanced ultrasound using sonazoid and gadolinium-ethoxybenzyl-diethylenetriamine penta-acetic acid magnetic resonance imaging of hepatocellular carcinoma lesions.

    Feiqian Wang, Kazushi Numata, Makoto Chuma, Haruo Miwa, Satoshi Moriya, Katsuaki Ogushi, Masahiro Okada, Masako Otani, Yoshiaki Inayama, Shin Maeda

    Journal of medical ultrasonics (2001)   48 ( 2 )   215 - 224   2021.4

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    PURPOSE: By analyzing possible factors contributing to imaging misevaluation of arterial phase (AP) vascularity, we aimed to provide a more proper way to detect AP hypervascularity of hepatocellular carcinomas (HCCs) using the noninvasive imaging modalities magnetic resonance imaging (MRI) and contrast-enhanced ultrasound (CEUS). METHODS: We retrospectively recruited 164 pathologically confirmed HCC lesions from 128 patients. Using CEUS with Sonazoid (SCEUS) and gadolinium-ethoxybenzyl-diethylenetriamine penta-acetic acid MRI (EOB-MRI), AP vascularity of the lesions was evaluated and inconsistencies in interpretation were examined. Indicators of margin, echogenicity, and halo and mosaic signs of lesions on grayscale US; depth of lesions on SCEUS; and tumoral homogeneity, signal contrast ratio of lesions to the surrounding area on precontrast and AP images on EOB-MRI, and histological grade were investigated. RESULTS: When precontrast images were used to adjust the AP enhancement ratio, the proportion of inconsistent interpretations of AP vascularity declined from 26.2% (43/164; 29 non-hypervascularity instances using EOB-MRI and 14 using SCEUS) to 16.5% (27/164; 7 using EOB-MRI and 20 using SCEUS). Greater lesion depth (P = 0.017), ill-defined tumoral margin (P = 0.028), absence of halo sign (P = 0.034), and histologically early HCC (P = 0.007) on SCEUS, and small size (P = 0.012) and heterogeneity (P = 0.013) of lesions and slight enhancement (low AP enhancement ratio) (P = 0.018 and 0.009 before and after adjustment) on EOB-MRI, may relate to undetectable hypervascularity. CONCLUSIONS: SCEUS and EOB-MRI may show discrepancies in evaluating AP vascularity in the case of deep, ill-defined, heterogeneous, slightly enhanced lesions, and histologically early HCCs. We recommend adjusting AP with precontrast images in EOB-MRI, and combining both modalities to detect hypervascularity.

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  • Tissue harmonic versus contrast-enhanced harmonic endoscopic ultrasonography for the diagnosis of pancreatic tumors: Prospective multicenter study. International journal

    Shunsuke Omoto, Masayuki Kitano, Mitsuharu Fukasawa, Reiko Ashida, Hironari Kato, Hideyuki Shiomi, Kazuya Sugimori, Atsushi Kanno, Yasutaka Chiba, Shinichi Takano, Naoki Yamamoto, Takeshi Ezaki, Haruo Miwa, Akitaka Yokomura, Masato Hoshikawa, Takamitsu Tanaka, Masatoshi Kudo

    Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society   34 ( 1 )   198 - 206   2021.2

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    OBJECTIVES: This prospective multicenter study aimed to assess and compare the accuracy of tissue harmonic endoscopic ultrasonography (TH-EUS) and contrast-enhanced harmonic endoscopic ultrasonography (CH-EUS) for differentiating pancreatic carcinoma from other pancreatic tumors. METHODS: Consecutive patients with solid pancreatic tumors were prospectively enrolled between August 2013 and December 2014. To assess the accuracy of TH-EUS and CH-EUS, we compared four parameters of TH-EUS (fuzzy edge, irregular periphery, hypoechogenicity, and heterogeneous internal echogenicity) and four parameters of CH-EUS (hypoenhancement and heterogeneous enhancement in the early and late phases, respectively) to investigate which parameter of each method was most suitable to diagnose pancreatic carcinomas. Interobserver agreement and the diagnostic ability of pancreatic carcinoma using TH-EUS and CH-EUS were assessed and compared. RESULTS: A total of 204 patients were enrolled. For the diagnosis of pancreatic carcinoma, interobserver agreement by experts and nonexperts was 0.33-0.50 and 0.35-0.50 for TH-EUS, respectively, and 0.72-0.74 and 0.20-0.54 for CH-EUS, respectively. Irregular periphery was the most accurate diagnostic parameter among TH-EUS findings for differentiating pancreatic carcinomas, with sensitivity, specificity, and accuracy of 95.0%, 42.9%, and 78.9%, respectively. Late phase hypoenhancement was the most accurate diagnostic parameter among CH-EUS findings for differentiating pancreatic carcinomas, with sensitivity, specificity, and accuracy of 90.8%, 74.6%, and 85.8%, respectively. The accuracy of CH-EUS (late phase hypoenhancement) for diagnosis of pancreatic carcinoma was significantly higher than that of TH-EUS (irregular periphery) (p < 0.001). CONCLUSION: In comparison with TH-EUS, CH-EUS increased the diagnostic ability and reproducibility for the diagnosis of pancreatic carcinoma. UMIN (000011124).

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  • Randomized Phase II Study of Gemcitabine Monotherapy vs. Gemcitabine with an EPA-Enriched Oral Supplement in Advanced Pancreatic Cancer. International journal

    Makoto Ueno, Kazuya Sugimori, Masataka Taguri, Shinichi Ohkawa, Satoshi Kobayashi, Haruo Miwa, Takashi Kaneko, Manabu Morimoto, Takeharu Yamanaka

    Nutrition and cancer   74 ( 1 )   1 - 10   2021.1

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    BACKGROUND: Pancreatic cancer is often associated with cachexia. It had been reported that eicosapentaenoic acid (EPA) improve cachexia. This study aimed to evaluate the efficacy and safety of gemcitabine with an EPA-enriched oral supplement in patients with advanced pancreatic cancer. METHODS: This open-label phase II study consisted of patients (pts) who were randomly categorized into the EPA group (1,000 mg/m2 gemcitabine was administered on day 1, 8, and 15, every 4 weeks while an EPA-enriched oral supplement (prosure®, EPA 1.056 mg per pack) was taken daily at the maximum of two packs or the gemcitabine monotherapy group with an allocation ratio of 2:1. The primary endpoint was the evaluation of the 1-year survival estimating 10% addition. RESULTS: Randomized 68 pts were examined (EPA: 45, gemcitabine: 23). The 1-year survival probability of the EPA group was 35% while the gemcitabine group was 19%. The median survival times were 8.2 and 9.7 mo, respectively. The hazard ratio for EPA group was 0.79 [95% CI 0.46-1.37]; (P = 0.40). The toxicities were mild and insignificant in both groups. More beneficial effects of EPA in survival were observed in men, pancreatic body-tail and low C-reactive protein patients. CONCLUSION: An EPA-enriched oral supplement may be effective in advanced pancreatic cancer.

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  • Quantitative monitoring of circulating tumor DNA in patients with advanced pancreatic cancer undergoing chemotherapy. International journal

    Makoto Sugimori, Kazuya Sugimori, Hiromi Tsuchiya, Yoshimasa Suzuki, Sho Tsuyuki, Yoshihiro Kaneta, Akane Hirotani, Katsuyuki Sanga, Yuichiro Tozuka, Satoshi Komiyama, Takeshi Sato, Shun Tezuka, Yoshihiro Goda, Kuniyasu Irie, Haruo Miwa, Yuuki Miura, Tomohiro Ishii, Takashi Kaneko, Masatsugu Nagahama, Wataru Shibata, Akito Nozaki, Shin Maeda

    Cancer science   111 ( 1 )   266 - 278   2020.1

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    According to cancer genome sequences, more than 90% of cases of pancreatic ductal adenocarcinoma (PDAC) harbor active KRAS mutations. Digital PCR (dPCR) enables accurate detection and quantification of rare mutations. We assessed the dynamics of circulating tumor DNA (ct-DNA) in patients with advanced PDAC undergoing chemotherapy using dPCR. KRAS G12/13 mutation was assayed by dPCR in 47 paired tissue- and ct-DNA samples. The 21 patients were subjected to quantitative ct-DNA monitoring at 4 to 8-week intervals during chemotherapy. KRAS mutation was detected in 45 of those 47 patients using tissue DNA. In the KRAS mutation-negative cases, next-generation sequencing revealed KRAS Q61K and NRAS Q61R mutations. KRAS mutation was detected in 23/45 cases using ct-DNA (liver or lung metastasis, 18/19; mutation allele frequency [MAF], 0.1%-31.7%; peritoneal metastasis, 3/9 [0.1%], locally advanced, 2/17 [0.1%-0.2%]). In the ct-DNA monitoring, the MAF value changed in concordance with the disease state. In the 6 locally advanced cases, KRAS mutation appeared concurrently with liver metastasis. Among the 6 cases with liver metastasis, KRAS mutation disappeared during the duration of stable disease or a partial response, and reappeared at the time of progressive disease. The median progression-free survival was longer in cases in which KRAS mutation disappeared after an initial course of chemotherapy than in those in which it was continuously detected (248.5 vs 50 days, P < .001). Therefore, ct-DNA monitoring enables continuous assessment of disease state and could have prognostic utility during chemotherapy.

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  • The Superiority of Vonoprazan-based First-line Triple Therapy with Clarithromycin: A Prospective Multi-center Cohort Study on Helicobacter pylori Eradication.

    Soichiro Sue, Hirofumi Kuwashima, Yuri Iwata, Hiroyuki Oka, Isao Arima, Takehide Fukuchi, Katsuyuki Sanga, Yasuhiro Inokuchi, Yuniba Ishii, Masatomo Kanno, Masahiro Terada, Hitoshi Amano, Makoto Naito, Shigeru Iwase, Hiroshi Okazaki, Kazuto Komatsu, Atsushi Kokawa, Ichiro Kawana, Manabu Morimoto, Toshifumi Saito, Yosuke Kunishi, Akihiko Ikeda, Daisuke Takahashi, Haruo Miwa, Tomohiko Sasaki, Toshihide Tamura, Masaaki Kondo, Wataru Shibata, Shin Maeda

    Internal medicine (Tokyo, Japan)   56 ( 11 )   1277 - 1285   2017

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    Objective We evaluated the safety and efficacy of vonoprazan-based amoxicillin and clarithromycin 7-day triple therapy (VAC) in comparison to proton pump inhibitor (PPI)-based (PAC) as a first-line treatment and vonoprazan-based amoxicillin and metronidazole 7-day triple therapy (VAM) in comparison to PPI-based (PAM) as a second-line treatment for the eradication of Helicobacter pylori in Japan. Methods We performed a non-randomized, multi-center, parallel-group study to compare first-line VAC to PAC and second-line VAM to PAM. A pre-planned subgroup analysis on CAM resistance was also performed. Safety was evaluated with an adverse effects questionnaire (AEQ), which was completed by patients during therapy. Results The first-line eradication rates (ER) in the intention-to-treat (ITT) and per protocol (PP) analyses were 84.9% (95% CI: 81.9-87.6%, n=623) and 86.4% (83.5-89.1%, n=612), respectively, for VAC and 78.8% (75.3-82.0%, n=608) and 79.4% (76.0-82.6%, n=603), respectively, for PAC. The ER of VAC was higher than that of PAC in the ITT (p=0.0061) and PP analyses (p=0.0013). The ERs for VAC in patients with CAM-resistant and CAM-susceptible bacteria were 73.2% (59.7-84.2%, n=56) and 88.9% (83.4-93.1%, n=180), respectively. PAC was associated with higher AEQ scores for diarrhea, nausea, headache, and general malaise. In the second-line ITT and PP analyses VAM achieved ERs of 80.5% (74.6-85.6%, n=216) and 82.4% (76.6-87.3%, n=211), respectively, while PAM achieved ERs of 81.5% (74.2-87.4%, n=146) and 82.1% (74.8-87.9%, n=145), respectively. No significant differences were observed in the ITT (p=0.89) or PP (p=1.0) analyses. Conclusion The ER of first-line VAC was higher than that of PAC, but still <90%. No difference was observed between second-line VAM and PAM. Vonoprazan-based triple therapy was safe and well tolerated.

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  • Diagnosis of pancreatic lesions collected by endoscopic ultrasound-guided fine-needle aspiration using next-generation sequencing Reviewed

    Eri Kameta, Kazuya Sugimori, Takashi Kaneko, Tomohiro Ishii, Haruo Miwa, Takeshi Sato, Yasuaki Ishii, Soichiro Sue, Tomohiko Sasaki, Yuki Yamashita, Wataru Shibata, Naomichi Matsumoto, Shin Maeda

    ONCOLOGY LETTERS   12 ( 5 )   3875 - 3881   2016.11

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    DOI: 10.3892/ol.2016.5168

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  • Intestine-specific homeobox (ISX) induces intestinal metaplasia and cell proliferation to contribute to gastric carcinogenesis Reviewed

    Soichiro Sue, Wataru Shibata, Eri Kameta, Takeshi Sato, Yasuaki Ishii, Hiroaki Kaneko, Haruo Miwa, Tomohiko Sasaki, Toshihide Tamura, Masaaki Kondo, Shin Maeda

    Journal of Gastroenterology   51 ( 10 )   949 - 960   2016.10

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    DOI: 10.1007/s00535-016-1176-2

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  • Case of a tumor comprising gastric cancer and duodenal neuroendocrine tumor. Reviewed International journal

    Hiroaki Kaneko, Akio Miyake, Yasuaki Ishii, Soichiro Sue, Haruo Miwa, Tomohiko Sasaki, Toshihide Tamura, Masaaki Kondo, Shin Maeda

    World journal of gastroenterology   22 ( 36 )   8242 - 6   2016.9

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  • Use of endoscopic ultrasound-guided fine needle aspiration to select a treatment plan in a patient with gallbladder carcinoma and a hepatic lesion

    ISHII YUNIBA, SUGIMORI KAZUYA, KUBO ATSUYOSHI, MIWA HARUO, KAMETA ERI, ISHII TOMOHIRO, KANEKO TAKASHI, TSUCHIYA NOBUHIRO, SEGAMI AKITAKA, MINAMI YUTA, KOKAWA ATSUSHI, NUMATA KAZUSHI, TANAKA KATSUAKI, OTANI MASAKO, INAYAMA YOSHIAKI, MAEDA SHIN

    Prog Dig Endosc   86 ( 1 )   216 - 217   2015

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  • Efficacy of plastic stent placement inside bile ducts for the treatment of unresectable malignant hilar obstruction (with videos).

    Takashi Kaneko, Kazuya Sugimori, Yuro Shimizu, Haruo Miwa, Eri Kameta, Ryonho Koh, Kazushi Numata, Katsuaki Tanaka, Shin Maeda

    Journal of hepato-biliary-pancreatic sciences   21 ( 5 )   349 - 55   2014.5

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    BACKGROUND: Recent reports have addressed the utility of plastic stent (PS) placement inside bile ducts for treating biliary obstructions. Here, we evaluated the utility and safety of PS placement inside bile ducts for treating unresectable malignant hilar biliary obstruction. METHODS: We conducted a retrospective study of 27 patients with unresectable malignant hilar biliary obstruction who underwent intraductal modified PS placement. We modified the PS, by cutting off the distal end to facilitate insertion through the papilla of Vater, and attached a nylon thread to the distal end for removal. We evaluated complications, the time to recurrent biliary obstruction (TRBO), and removability. RESULTS: Bilateral stenting was performed in nine of the 27 patients. Mild acute pancreatitis occurred in one patient (4%). Recurrent biliary obstruction (RBO) occurred in 16 patients (59%), with a median TRBO of 190 days (95% confidence interval: 174-205 days). Reintervention was necessary in 13 of the 16 patients (81%) with RBO, and we were able to remove the initial stents in all the patients who required reintervention. CONCLUSIONS: A relatively long stent patency period (>6 months) and removability make placement of a modified PS inside bile ducts a viable treatment for unresectable malignant hilar biliary obstruction.

    DOI: 10.1002/jhbp.41

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  • Contrast-enhanced ultrasonography findings using a perflubutane-based contrast agent in patients with early hepatocellular carcinoma. International journal

    Kazushi Numata, Hiroyuki Fukuda, Haruo Miwa, Tomohiro Ishii, Satoshi Moriya, Masaaki Kondo, Akito Nozaki, Manabu Morimoto, Masahiro Okada, Shigeo Takebayashi, Shin Maeda, Akinori Nozawa, Masayuki Nakano, Katsuaki Tanaka

    European journal of radiology   83 ( 1 )   95 - 102   2014.1

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    OBJECTIVE: We evaluated the contrast-enhanced ultrasonography (US) imaging features of early hepatocellular carcinomas (HCCs) and compared these findings with those obtained using contrast-enhanced computed tomography (CT). SUBJECTS AND METHODS: Forty-three patients with 52 early HCCs with a mean maximal diameter of 15.6mm were enrolled in this retrospective study. After confirming the location of the target lesion using fusion imaging combining conventional US and hepatobiliary phase of contrast-enhanced magnetic resonance (MR) imaging with gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid, we evaluated findings of contrast-enhanced US using a perflubutane-based contrast agent. The contrast-enhanced US detection rates for hyper-vascularity in early HCCs were compared with those obtained for contrast-enhanced CT. RESULTS: Transient hypo-vascularity subsequent to iso-vascularity during arterial phase and iso-vascularity during portal and post-vascular phases were the predominant contrast-enhanced US findings seen for 25 (48.1%) of the 52 early HCCs. Nine (17.3%) showed iso-vascularity during all three phases, while 1 (1.9%) showed hypo-vascularity during all three phases. The remaining 17 (32.7%) showed partial or whole hyper-vascularity during arterial phase, iso-vascularity during portal phase, and iso- or hypo-vascularity during post-vascular phase. The detection rate for the hyper-vascularity of early HCCs using contrast-enhanced US (32.7%, 17/52) was significantly higher than that obtained using contrast-enhanced CT (21.2%, 11/52) (P<0.05 by McNemar test). CONCLUSION: Hypo-vascularity, iso-vascularity, and hyper-vascularity were observed during the arterial phase of contrast-enhanced US in 50.0%, 17.3%, and 32.7% of the early HCCs, respectively. Contrast-enhanced US was more sensitive than contrast-enhanced CT for the detection of hyper-vascularity in early HCCs. Of note, early HCCs might not exhibit the early arterial enhancement that is generally considered to be a typical finding for HCCs.

    DOI: 10.1016/j.ejrad.2013.09.025

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  • [The clinical outcomes of endoscopic stent placement for patients with malignant gastric outlet obstruction - a comparison with gastrojejunostomy]. Reviewed

    Tsuchida K, Kunisaki C, Shirai J, Watanabe T, Ono H, Oshima T, Fukushima T, Miwa H, Kaneko T, Sugimori K, Yukawa N, Yoshikawa T, Rino Y, Imada T, Masuda M

    Gan to kagaku ryoho. Cancer & chemotherapy   40 ( 12 )   1690 - 1692   2013.11

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  • Combination chemotherapy of S-1 and CPT-11 for advanced recurrent gastric cancer Reviewed

    Osamu Akasaka, Shigeru Iwase, Haruo Miwa, Tomoko Ando, Seie Morita, Ryonho Koh, Miho Kasama, Rie Matsueda, Hideaki Anan

    Japanese Journal of Cancer and Chemotherapy   36 ( 11 )   1833 - 1837   2009

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  • 膵腫瘍の診断におけるティッシュハーモニックEUSと造影ハーモニックEUSの比較 多施設共同前向き研究

    大本 俊介, 北野 雅之, 深澤 光晴, 蘆田 玲子, 加藤 博也, 塩見 英之, 杉森 一哉, 菅野 敦, 千葉 康敬, 高野 伸一, 山本 直樹, 江崎 健, 三輪 治生, 横村 明高, 星川 聖人, 田中 隆光, 工藤 正俊

    Gastroenterological Endoscopy   64 ( 10 )   2323 - 2333   2022.10

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  • CLINICAL UTILITY OF THE QUANTITATIVE MONITORING OF CIRCULATING TUMOR DNA IN PATIENTS WITH ADVANCED PDAC UNDERGOING CHEMOTHERAPY

    Makoto Sugimori, Kazuya Sugimori, Chiaya Jimbo, Sho Tsuyuki, Yoshihiro Kaneta, Akane Hirotani, Katsuyuki Sanga, Satoshi Komiyama, Takeshi Sato, Shun Tezuka, Yoshihiro Goda, Kuniyasu Irie, Haruo Miwa, Yuuki Miura, Tomohiro Ishii, Wataru Shibata, Akito Nozaki, Shin Maeda

    GASTROENTEROLOGY   156 ( 6 )   S498 - S498   2019.5

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  • Practice of Genome Diagnosis in Pancreatic Tumor

    Makoto Sugimori, Kazuya Sugimori, Chigaya Jimbo, Akane Hirotani, Katsuyuki Sanga, Takeshi Sato, Shun Tezuka, Yoshihiro Goda, Kuniyasu Irie, Haruo Miwa, Wataru Shibata, Akito Nozaki, Shin Maeda

    CANCER SCIENCE   109   711 - 711   2018.12

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  • Differential Diagnosis of Polypoid Lesions of the Gallbladder Using Contrast-Enhanced Ultrasonography With High Mechanical Index Contrast Mode

    Haruo Miwa, Kazushi Numata, Tomohiro Ishii, Takashi Kaneko, Wataru Shibata, Kazuya Sugimori, Katsuaki Tanaka, Shin Maeda

    GASTROENTEROLOGY   148 ( 4 )   S429 - S429   2015.4

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  • Diagnosis for Pancreatic Lesions Collected With the Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-FNA) by Next Generation Sequencing

    Eri Kameta, Kazuya Sugimori, Yasuaki Ishii, Takeshi Sato, Soichiro Sue, Haruo Miwa, Tomohiro Ishii, Takashi Kaneko, Wataru Shibata, Shin Maeda

    GASTROENTEROLOGY   148 ( 4 )   S338 - S338   2015.4

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  • Subgroup analyses of randomized phase II study on gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer.

    Makoto Ueno, Shinichi Ohkawa, Satoshi Kobayashi, Kazuya Sugimori, Taku Kaneko, Ryo Kameda, Tomoko Andou, Haruo Miwa, Ryonho Ko, Katsuaki Tanaka, Manabu Morimoto, Masataka Taguri, Satoshi Morita

    JOURNAL OF CLINICAL ONCOLOGY   32 ( 15 )   2014.5

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  • Randomized phase II study of gemcitabine monotherapy versus gemcitabine with an EPA-enriched oral supplement in advanced pancreatic cancer.

    Makoto Ueno, Satoshi Kobayashi, Shinichi Ohkawa, Ryo Kameda, Tomoko Andou, Kazuya Sugimori, Haruo Miwa, Ryonho Ko, Katsuaki Tanaka, Masataka Taguri, Satoshi Morita

    JOURNAL OF CLINICAL ONCOLOGY   31 ( 15 )   2013.5

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  • Differential Diagnosis of Solid Pancreatic Lesions by Using Three-Dimensional Contrast Enhanced Ultrasonography With High Mechanical Index Mode

    Haruo Miwa, Kazushi Numata, Toru Tanabe, Ryonho Koh, Takashi Kaneko, Kazuya Sugimori, Katsuaki Tanaka, Shin Maeda

    GASTROENTEROLOGY   142 ( 5 )   S617 - S617   2012.5

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