Prospective Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 7, 2016; 22(5): 1891-1901
Published online Feb 7, 2016. doi: 10.3748/wjg.v22.i5.1891
Diagnostic and therapeutic single-operator cholangiopancreatoscopy in biliopancreatic diseases: Prospective multicenter study in Japan
Toshio Kurihara, Ichiro Yasuda, Hiroyuki Isayama, Toshio Tsuyuguchi, Taketo Yamaguchi, Ken Kawabe, Yoshinobu Okabe, Keiji Hanada, Tsuyoshi Hayashi, Takao Ohtsuka, Syuhei Oana, Hiroshi Kawakami, Yoshinori Igarashi, Kazuya Matsumoto, Kiichi Tamada, Shomei Ryozawa, Hiroki Kawashima, Yutaka Okamoto, Iruru Maetani, Hiroyuki Inoue, Takao Itoi
Toshio Kurihara, Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan
Ichiro Yasuda, First Department of Internal Medicine, Gifu University Hospital, Gifu 501-1194, Japan
Hiroyuki Isayama, Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo 113-8655, Japan
Toshio Tsuyuguchi, Department of Gastroenterology and Nephrology, Chiba University Graduate School of Medicine, Chiba 260-8677, Japan
Taketo Yamaguchi, Department of Gastroenterology, Chiba Cancer Center, Funabashi Municipal Hospital, Chiba 260-8717, Japan
Ken Kawabe, Department of Gastroenterology, Clinical Research Institute, National Hospital Organization, Kyushu Medical Center, Fukuoka 810-8563, Japan
Yoshinobu Okabe, Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume 830-0011, Japan
Keiji Hanada, Department of Gastroenterology, Onomichi General Hospital, Onomichi 722-8508, Japan
Tsuyoshi Hayashi, Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, Sapporo 060-8543, Japan
Takao Ohtsuka, Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka 812-8582, Japan
Syuhei Oana, Department of Gastroenterology, Iwate Medical University, Morioka 020-0023, Japan
Hiroshi Kawakami, Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Sapporo 060-8648, Japan
Yoshinori Igarashi, Division of Gastroenterology and Hepatology, Omori Medical Center, Toho University, Tokyo 143-0015, Japan
Kazuya Matsumoto, Department of Gastroenterology, Tottori University Hospital, Yonago 683-8504, Japan
Kiichi Tamada, Department of Internal Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke 329-0498, Japan
Shomei Ryozawa, Department of Gastroenterology, Digestive Disease Center, Showa University, Northern Yokohama Hospital, Yokohama 224-0032, Japan
Hiroki Kawashima, Department of Gastroenterology and Hepatology, Graduate School of Medicine, Nagoya University, Nagoya 466-8550, Japan
Yutaka Okamoto, Department of Gastroenterology, Mutsu General Hospital, Mutsu 035-0071, Japan
Iruru Maetani, Division of Gastroenterology, Department of Internal Medicine, Ohashi Medical Center, Toho University, Tokyo 153-0044, Japan
Hiroyuki Inoue, Department of Gastroenterology, Mie University, Tsu 514-8507, Japan
Author contributions: Kurihara T designed the research study and wrote the paper; Yasuda I participated in designing and overseeing the study, data collection, and data analysis; Isayama H participated in designing the study; Tsuyuguchi T participated in overseeing the study and data collection; Yamaguchi T was involved with data collection; Kawabe K participated in data collection; Okabe Y assisted with data analysis and was involved with data collection; Hanada K, Hayashi T, Ohtsuka T, Oana S, Igarashi Y, Matsumoto K, Tamada K, Ryozawa S, Kawashima H, Okamoto Y, Maetani I and Inoue H were involved with data collection; Kawakami H participated in designing the study and assisted with data analysis; Itoi T designed the research study and wrote the paper; all authors read and approved the final manuscript.
Institutional review board statement: The study was approved by the Institutional Review Boards or Ethics Committees of all participating centers.
Clinical trial registration statement: The clinical trial was registered at UMIN CTR (http://www.umin.ac.jp). The registration identification number is UMIN000015155.
Informed consent statement: All study participants, or their legal guardian, provided written consent prior to study enrollment.
Conflict-of-interest statement: The authors have no conflicts of interest to disclose.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Toshio Kurihara, MD, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan. kurihara618@gmail.com
Telephone: +81-3-33426111 Fax: +81-3-53816654
Received: May 1, 2015
Peer-review started: May 8, 2015
First decision: June 19, 2015
Revised: July 14, 2015
Accepted: September 30, 2015
Article in press: September 30, 2015
Published online: February 7, 2016
Processing time: 264 Days and 24 Hours
Abstract

AIM: To assess the utility and safety of single-operator cholangiopancreatoscopy (SOCPS) using the SpyGlass system in widespread clinical application for biliary and pancreatic diseases.

METHODS: This study was a prospective case series conducted in 20 referral centers in Japan. There were 148 patients who underwent SOCPS; 124 for biliary diseases and 24 for pancreatic diseases. The attempted interventions were SOCPS examination, SOCPS-directed tissue sampling, and therapy for stone removal, among others. The main outcomes were related to the procedure success rate in terms of visualizing the target lesions, SOCPS-directed adequate tissue sampling, and complete stone removal.

RESULTS: A total of 148 patients were enrolled for the diagnosis of indeterminate biliary and pancreatic lesions or treatment of biliary and pancreatic disease. The overall procedure success rate of visualizing the target lesions was 91.2% (135/148). The overall procedural success rates of visualizing the target lesions of diagnostic SOCPS in the bile duct and pancreatic duct were 95.5% (84/89) and 88.2% (15/17), respectively. Diagnosis: the overall adequate tissue for histologic examination was secured in 81.4% of the 86 patients who underwent biopsy under SOCPS (bile duct, 60/75, 80.0%; pancreatic duct, 10/11, 90.9%). The accuracy of histologic diagnosis using SOCPS-directed biopsies in indeterminate bile duct lesions was 70.7% (53/75). In the pancreatic duct, the accuracy of SOCPS visual impression of intraductal papillary mucinous neoplasm was 87.5% (14/16). Stone therapy: complete biliary and pancreatic stone clearance combined with SOCPS-directed stone therapy using electrohydraulic lithotripsy or laser lithotripsy was achieved in 74.2% (23/31) and 42.9% (3/7) of the patients, respectively. Others: SOCPS using the SpyGlass system was used in cannulation of the cystic duct in two patients and for passing across the obstructed self-expandable metallic stent for a malignant biliary stricture in two patients. All procedures were successful in both SOCPS-guided therapies. The incidence of procedure-related adverse events was 5.4% (8/148).

CONCLUSION: SOCPS with direct visualization and biopsy for diagnosis and SOCPS-directed therapy for biliary and pancreatic diseases can be safely performed with a high success rate.

Keywords: Cholangioscopy; Endoscopic retrograde cholangiopancreatography; Pancreatoscopy; Single-operator; SpyGlass

Core tip: This investigation was a prospective, multicenter study in Japan involving 148 enrolled patients in whom the utility and safety of single-operator cholangiopancreatoscopy (SOCPS) with the SpyGlass system in pancreatobiliary disorders were analyzed. SOCPS with direct visualization and biopsy for diagnosis, and SOCPS-directed therapy for biliary and pancreatic diseases can be safely performed with a high success rate.