Mio Matsumoto1, Mototsugu Kato2, Koji Oba3, Satoshi Abiko4, Momoko Tsuda4, Shuichi Miyamoto4, Takeshi Mizushima4, Masayoshi Ono4, Saori Omori5, Masakazu Takahashi2, Shoko Ono2, Katsuhiro Mabe6, Manabu Nakagawa2, Soichi Nakagawa2, Takahiko Kudo7, Yuichi Shimizu4, Naoya Sakamoto4. 1. Department of Gastroenterology, Sapporo Medical Center NTT EC, Sapporo, Japan. 2. Division of Endoscopy, Hokkaido University Hospital, Sapporo, Japan. 3. Department of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. 4. Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Sapporo, Japan. 5. Department of Gastroenterology, lwamizawa Municipal General Hospital, Iwamizawa, Japan. 6. Department of Cancer Preventive Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan. 7. Department of Gastroenterology, Sapporo City General Hospital, Sapporo, Japan.
Abstract
BACKGROUND AND AIM: Prophylactic clipping has been widely used to prevent post-procedural bleeding in colon polypctomy. However, its efficiency has not been confirmed and there is no consensus on the usefulness of prophylactic clipping. The aim of the present study was to evaluate the preventive effect of prophylactic clipping on post-polypectomy bleeding. METHODS: A multicenter randomized controlled study was conducted from January 2012 to July 2013 in Japan. Patients who had polyps <2 cm in diameter were divided into a clipping group and a non-clipping group by cluster randomization. After endoscopic polypectomy, patients allocated to the clipping group underwent prophylactic clipping, whereas the procedure was completed without clipping in patients allocated to the non-clipping group. Occurrence of post-polypectomy bleeding was compared between the two groups. RESULTS:Seven hospitals participated in this study. A total of 3365 polyps in 1499 patients were evaluated. The clippinggroup consisted of 1636 polyps in 752 patients, and the non-clipping group consisted of 1729 polyps in 747 patients. Post-polypectomy bleeding occurred in 1.10% (18/1636) of the cases in the clipping group, and in 0.87% (15/1729) of those in the non-clipping group. The difference was -0.22% (95% confidence interval [CI]: -0.96, 0.53). Upper limit of the 95% CI was lower than the non-inferiority margin (1.5%), and we could thus prove non-inferiority of non-clipping against clipping. CONCLUSION:Prophylactic clipping is not necessary to prevent post-polypectomy bleeding for polyps <2 cm in diameter.
RCT Entities:
BACKGROUND AND AIM: Prophylactic clipping has been widely used to prevent post-procedural bleeding in colon polypctomy. However, its efficiency has not been confirmed and there is no consensus on the usefulness of prophylactic clipping. The aim of the present study was to evaluate the preventive effect of prophylactic clipping on post-polypectomy bleeding. METHODS: A multicenter randomized controlled study was conducted from January 2012 to July 2013 in Japan. Patients who had polyps <2 cm in diameter were divided into a clipping group and a non-clipping group by cluster randomization. After endoscopic polypectomy, patients allocated to the clipping group underwent prophylactic clipping, whereas the procedure was completed without clipping in patients allocated to the non-clipping group. Occurrence of post-polypectomy bleeding was compared between the two groups. RESULTS: Seven hospitals participated in this study. A total of 3365 polyps in 1499 patients were evaluated. The clipping group consisted of 1636 polyps in 752 patients, and the non-clipping group consisted of 1729 polyps in 747 patients. Post-polypectomy bleeding occurred in 1.10% (18/1636) of the cases in the clipping group, and in 0.87% (15/1729) of those in the non-clipping group. The difference was -0.22% (95% confidence interval [CI]: -0.96, 0.53). Upper limit of the 95% CI was lower than the non-inferiority margin (1.5%), and we could thus prove non-inferiority of non-clipping against clipping. CONCLUSION: Prophylactic clipping is not necessary to prevent post-polypectomy bleeding for polyps <2 cm in diameter.
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