Clinical Trials Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 7, 2017; 23(9): 1645-1656
Published online Mar 7, 2017. doi: 10.3748/wjg.v23.i9.1645
Outcomes of gastrointestinal defect closure with an over-the-scope clip system in a multicenter experience: An analysis of a successful suction method
Hideki Kobara, Hirohito Mori, Shintaro Fujihara, Noriko Nishiyama, Taiga Chiyo, Takayoshi Yamada, Masao Fujiwara, Keiichi Okano, Yasuyuki Suzuki, Masayuki Murota, Yoshitaka Ikeda, Makoto Oryu, Mohamed AboEllail, Tsutomu Masaki
Hideki Kobara, Hirohito Mori, Shintaro Fujihara, Noriko Nishiyama, Taiga Chiyo, Tsutomu Masaki, Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Kagawa 761-0793, Japan
Takayoshi Yamada, Department of Gastroenterology, Kochi Health Sciences Center, Kochi 781-8555, Japan
Masao Fujiwara, Keiichi Okano, Yasuyuki Suzuki, Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa Prefecture 760-0016, Japan
Masayuki Murota, Department of Gastroenterology, Sakaide City Hospital, Kagawa Prefecture 762-8550, Japan
Yoshitaka Ikeda, Department of Surgery, Ehime Rosai Hospital, Ehime Prefecture 792-0863, Japan
Makoto Oryu, Department of Gastroenterology, Kagawa Saiseikai Hospital, Kagawa 761-0793, Japan
Mohamed AboEllail, Department of Gynecology, Faculty of Medicine, Kagawa University, Kagawa 761-0793, Japan
Author contributions: Kobara H and Mori H were responsible for the study concept and design; Yamada T, Murota M, Ikeda Y and Oryu M were responsible for the acquisition of the data; Nishiyama N and Chiyo T were responsible for the analysis and interpretation of the data; Fujiwara M, Okano K and Suzuki Y supplied the material; Fujihara S was responsible for the statistical analysis; AboEllail M was responsible for drafting the manuscript; and Masaki T was responsible for the study supervision.
Institutional review board statement: This study was reviewed and approved by the Ethics Committee of the Kagawa Medical University Hospital and each institution.
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment by written consent. For full disclosure, the details of the study are published on the home page of the Kagawa Medical University Hospital and each institution.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at Informed consent form participants for data sharing was not obtained but the presented data are anonymized and risk of identification is low.
Conflict-of-interest statement: The authors have no conflicts of interest to report.
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:
Correspondence to: Hideki Kobara, MD, PhD, Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan.
Telephone: +81-87-8912156 Fax: +81-87-8912158
Received: November 30, 2016
Peer-review started: December 2, 2016
First decision: December 28, 2016
Revised: January 12, 2017
Accepted: February 7, 2017
Article in press: February 8, 2017
Published online: March 7, 2017

To demonstrate the clinical outcomes of a multicenter experience and to suggest guidelines for choosing a suction method.


This retrospective study at 5 medical centers involved 58 consecutive patients undergoing over-the-scope clips (OTSCs) placement. The overall rates of technical success (TSR), clinical success (CSR), complications, and procedure time were analyzed as major outcomes. Subsequently, 56 patients, excluding two cases that used the Anchor device, were divided into two groups: 14 cases of simple suction (SS-group) and 42 cases using the Twin Grasper (TG-group). Secondary evaluation was performed to clarify the predictors of OTSC success.


The TSR, CSR, complication rate, and median procedure time were 89.7%, 84.5%, 1.8%, and 8 (range 1-36) min, respectively, demonstrating good outcomes. However, significant differences were observed between the two groups in terms of the mean procedure time (5.9 min vs 14.1 min). The CSR of the SS- and TG-groups among cases with a maximum defect size ≤ 10 mm and immediate or acute refractory bleeding was 100%, which suggests that SS is a better method than TG in terms of time efficacy. The CSR in the SS-group (78.6%), despite the technical success of the SS method (TSR, 100%), tended to decrease due to delayed leakage compared to that in the TG-group (TSR, CSR; 88.1%), indicating that TG may be desirable for leaks and fistulae with defects of the entire layer.


OTSC system is a safe and effective therapeutic option for gastrointestinal defects. Individualized selection of the suction method based on particular clinical conditions may contribute to the improvement of OTSC success.

Keywords: Over-the-scope clip, Leak, Gastrointestinal refractory bleeding, Fistula, Endoscopic closure

Core tip: The efficacy of over-the-scope clips (OTSCs) for gastrointestinal defects has been widely known. However, few large studies with more than 50 cases have been performed. Additionally, an optimal strategy for selecting a suction method, which is a critical factor of OTSC success, is needed. This study, with a large number of cases and a multicenter design, demonstrated excellent outcomes of OTSC and revealed which type of suction method was appropriate for particular situations according to the following characteristics: defect size, duration since onset, and indication. The individualized choice of the suction method is the most important factor determining OTSC success.