Takuya Inoue1,2, Ryu Ishihara3, Tsutomu Nishida4, Tomofumi Akasaka3,5, Yoshito Hayashi1, Dai Nakamatsu4,6, Hideharu Ogiyama7, Shinjiro Yamaguchi8, Katsumi Yamamoto9, Akira Mukai10, Kazuo Kinoshita11, Takayuki Yakushijin2, Hideki Iijima1, Tetsuo Takehara1,12. 1. Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Japan. 2. Department of Gastroenterology and Hepatology, Osaka General Medical Center, Osaka, Japan. 3. Department of Gastrointestinal Oncology, Osaka International Cancer Center, Osaka, Japan. 4. Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka, Japan. 5. Department of Gastroenterology and Hepatology, National Hospital Organization Osaka National Hospital, Osaka, Japan. 6. Department of Gastroenterology, Kaizuka City Hospital, Kaizuka, Japan. 7. Department of Gastroenterology, Itami City Hospital, Itami, Japan. 8. Department of Gastroenterology, Kansai Rosai Hospital, Amagasaki, Japan. 9. Department of Gastroenterology, Japan Community Healthcare Organization Osaka Hospital, Osaka, Japan. 10. Department of Gastroenterology, Sumitomo Hospital, Osaka, Japan. 11. Department of Gastroenterology, Otemae Hospital, Osaka, Japan. 12. Osaka Gut Forum, Osaka, Japan.
Abstract
BACKGROUND AND AIM: Prophylactic clipping (PC) after polypectomy has the potential to prevent post-polypectomy bleeding (PPB). We aimed to evaluate the effectiveness of PC in preventing PPB for < 20-mm polyps. METHODS: This multicenter, open-label, randomized controlled trial conducted from December 2013 to June 2017 at 10 institutions randomly assigned 1080 patients with < 20-mm colon polyps to the non-PC and PC groups. Allocation factors were institution, antiplatelet drug use, and polyp number. The primary endpoint was differences in PPB rates between the groups. The severity of PPB and post-procedural abdominal symptoms were also investigated. These endpoints in intention-to-treat and per-protocol (PP) analyses were evaluated. RESULTS: We investigated 1039 patients with 2960 lesions. There was no significant difference between the groups in characteristics including age, sex, hypertension, diabetes, hyperlipidemia, antiplatelet drug use, and lesion characteristics such as type and size. Excluding the clip used in the non-PC group, intraoperative bleeding, and deviation of protocol, 903 patients were investigated in PP analysis. There was no significant difference in the PPB rate between the non-PC and PC groups (2.7% vs 2.3%, P = 0.6973 [intention-to-treat analysis]; 3.0 vs 2.4%, P = 0.7353 [PP analysis]). Severe PPB (≥ grade 3) was similar between the groups. Total procedure time was significantly shorter in the non-PC group than in the PC group (31 vs 36 min, P = 0.0002). Post-procedural abdominal fullness was less common in the non-PC group than in the PC group (20.8% vs 25.6%, P = 0.0833). CONCLUSION:Prophylactic clipping is not effective in preventing PBB for < 20-mm colon polyps (UMIN000012163).
RCT Entities:
BACKGROUND AND AIM: Prophylactic clipping (PC) after polypectomy has the potential to prevent post-polypectomy bleeding (PPB). We aimed to evaluate the effectiveness of PC in preventing PPB for < 20-mm polyps. METHODS: This multicenter, open-label, randomized controlled trial conducted from December 2013 to June 2017 at 10 institutions randomly assigned 1080 patients with < 20-mm colon polyps to the non-PC and PC groups. Allocation factors were institution, antiplatelet drug use, and polyp number. The primary endpoint was differences in PPB rates between the groups. The severity of PPB and post-procedural abdominal symptoms were also investigated. These endpoints in intention-to-treat and per-protocol (PP) analyses were evaluated. RESULTS: We investigated 1039 patients with 2960 lesions. There was no significant difference between the groups in characteristics including age, sex, hypertension, diabetes, hyperlipidemia, antiplatelet drug use, and lesion characteristics such as type and size. Excluding the clip used in the non-PC group, intraoperative bleeding, and deviation of protocol, 903 patients were investigated in PP analysis. There was no significant difference in the PPB rate between the non-PC and PC groups (2.7% vs 2.3%, P = 0.6973 [intention-to-treat analysis]; 3.0 vs 2.4%, P = 0.7353 [PP analysis]). Severe PPB (≥ grade 3) was similar between the groups. Total procedure time was significantly shorter in the non-PC group than in the PC group (31 vs 36 min, P = 0.0002). Post-procedural abdominal fullness was less common in the non-PC group than in the PC group (20.8% vs 25.6%, P = 0.0833). CONCLUSION: Prophylactic clipping is not effective in preventing PBB for < 20-mm colon polyps (UMIN000012163).