Takahito Katano1, Takaya Shimura2, Satoshi Nomura1,3, Tomohiro Iwai4, Yusuke Mizuno5, Tomonori Yamada5, Masahide Ebi6, Yoshikazu Hirata7, Hirotada Nishie1, Takashi Mizushima8, Yu Nojiri1,9, Shozo Togawa9, Hiroki Koguchi10, Shunsuke Shibata4, Noriyuki Hayashi7, Keisuke Itoh11, Hiromi Kataoka1. 1. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan. 2. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan. tshimura@med.nagoya-cu.ac.jp. 3. Department of Gastroenterology, Nagoya City West Medical Center, 1-1-1 Hirate, Kita-ku, Nagoya, 462-8508, Japan. 4. Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan. 5. Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya, 466-0814, Japan. 6. Department of Gastroenterology, Aichi Medical University, 1-1 Karimata, Iwasaku, Nagakute, 480-1195, Japan. 7. Department of Gastroenterology, Kasugai Municipal Hospital, 1-1-1 Takaki, Kasugai, 486-0000, Japan. 8. Department of Gastroenterology, Gifu Prefectural Tajimi Hospital, 5-161 Maehata, Tajimi, 507-8522, Japan. 9. Department of Gastroenterology, Nagoya Memorial Hospital, 4-305 Hirabari, Tenpaku-ku, Nagoya, 468-8520, Japan. 10. Department of Gastroenterology, Chukyo Hospital, 1-1-10 Sanjyo, Minami-ku, Nagoya, 457-8510, Japan. 11. Department of Gastroenterology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, 464-8547, Japan.
Abstract
PURPOSE:Endoscopic clipping closure after colorectal endoscopic submucosal dissection (ESD) did not reduce the incidence of post-ESD coagulation syndrome (PECS) in our recent randomized controlled trial (RCT); however, the definition of PECS is still controversial. The aim of this study is to establish optimal definition of PECS with additional analysis of RCT based on another definition. METHODS: In this multicenter, single-blind RCT, individuals were randomly assigned to colorectal ESD followed by endoscopic clipping closure or non-closure. In this post hoc analysis, the definition of PECS was modified as both localized abdominal pain on visual analogue scale and inflammatory response (fever or leukocytosis), from either localized abdominal pain or inflammatory response in the original study. All participants underwent a computed tomography after ESD, and PECS was classified into type I, conventional PECS without extra-luminal air, and type II, PECS with peri-luminal air. RESULTS: A total of 155 patients (84 in the non-closure group and 71 in the closure group) were analyzed. As a result of criteria modification, 21 type I PECS and four type II PECS cases in the original study, which included patients with clear pain and inflammatory response, were downgraded to no adverse event and simple peri-luminal air, respectively. The frequency of PECS showed no significant difference between non-closure and closure groups. CONCLUSION: Clipping closure after colorectal ESD does not reduce the incidence of PECS regardless of the diagnostic criteria. Either localized abdominal pain or inflammatory response might be optimal criteria of PECS (UMIN000027031). TRIAL REGISTRATION NUMBER: UMIN000027031 DATE OF REGISTRATION: April 18, 2017.
RCT Entities:
PURPOSE: Endoscopic clipping closure after colorectal endoscopic submucosal dissection (ESD) did not reduce the incidence of post-ESD coagulation syndrome (PECS) in our recent randomized controlled trial (RCT); however, the definition of PECS is still controversial. The aim of this study is to establish optimal definition of PECS with additional analysis of RCT based on another definition. METHODS: In this multicenter, single-blind RCT, individuals were randomly assigned to colorectal ESD followed by endoscopic clipping closure or non-closure. In this post hoc analysis, the definition of PECS was modified as both localized abdominal pain on visual analogue scale and inflammatory response (fever or leukocytosis), from either localized abdominal pain or inflammatory response in the original study. All participants underwent a computed tomography after ESD, and PECS was classified into type I, conventional PECS without extra-luminal air, and type II, PECS with peri-luminal air. RESULTS: A total of 155 patients (84 in the non-closure group and 71 in the closure group) were analyzed. As a result of criteria modification, 21 type I PECS and four type II PECS cases in the original study, which included patients with clear pain and inflammatory response, were downgraded to no adverse event and simple peri-luminal air, respectively. The frequency of PECS showed no significant difference between non-closure and closure groups. CONCLUSION: Clipping closure after colorectal ESD does not reduce the incidence of PECS regardless of the diagnostic criteria. Either localized abdominal pain or inflammatory response might be optimal criteria of PECS (UMIN000027031). TRIAL REGISTRATION NUMBER: UMIN000027031 DATE OF REGISTRATION: April 18, 2017.