Yoji Takeuchi1, Katsuhiro Mabe2, Yuichi Shimodate3, Shinji Yoshii4, Shinya Yamada5, Mineo Iwatate6, Takuji Kawamura7, Kinichi Hotta8, Koji Nagaike9, Nobuaki Ikezawa10, Tomoaki Yamasaki11, Yoriaki Komeda12, Satoshi Asai13, Yasuhiro Abe14, Takuji Akamatsu15, Yuko Sakakibara16, Hisatomo Ikehara17, Yuzuru Kinjo18, Takashi Ohta19, Yoko Kitamura20, Takashi Shono21, Takuya Inoue22, Yoshio Ohda23, Nozomu Kobayashi24, Tokuma Tanuma25, Ryu Sato26, Taku Sakamoto27, Naohiko Harada28, Akiko Chino29, Hideki Ishikawa30, Masanori Nojima31, Toshio Uraoka32. 1. Osaka International Cancer Institute, Osaka, Japan (Y.T.). 2. National Hospital Organization Hakodate National Hospital, Hakodate, Japan (K.M.). 3. Kurashiki Central Hospital, Kurashiki, Japan (Y.S.). 4. Sapporo Medical Center Nippon Telegraph and Telephone East Corporation, Sapporo, Japan (S.Y.). 5. Ishikawa Prefectural Central Hospital, Kanazawa, Japan (S.Y.). 6. Sano Hospital, Kobe, Japan (M.I.). 7. Kyoto Second Red Cross Hospital, Kyoto, Japan (T.K.). 8. Shizuoka Cancer Center, Suntogun, Shizuoka, Japan (K.H.). 9. Suita Municipal Hospital, Suita, Japan (K.N.). 10. Akashi Medical Center, Akashi, Japan (N.I.). 11. Osaka City General Hospital, Osaka, Japan (T.Y.). 12. Kindai University Faculty of Medicine, Osaka-Sayama, Japan (Y.K.). 13. Tane General Hospital, Osaka, Japan (S.A.). 14. Utsunomiya Memorial Hospital, Tochigi, Japan (Y.A.). 15. Japanese Red Cross Society Wakayama Medical Center, Wakayama, Japan (T.A.). 16. National Hospital Organization Osaka National Hospital, Osaka, Japan (Y.S.). 17. Nihon University School of Medicine, Tokyo, Japan (H.I.). 18. Naha City Hospital, Naha, Japan (Y.K.). 19. Kansai Rosai Hospital, Amagasaki, Japan (T.O.). 20. Nara City Hospital, Nara, Japan (Y.K.). 21. Kumamoto University, Kumamoto, Japan (T.S.). 22. Osaka General Medical Center, Osaka, Japan (T.I.). 23. Hyogo College of Medicine, Nishinomiya, Japan (Y.O.). 24. Tochigi Cancer Center, Utsunomiya, Japan (N.K.). 25. Teine Keijinkai Hospital, Sapporo, Japan (T.T.). 26. Sapporo Higashi Tokushukai Hospital, Sapporo, Japan (R.S.). 27. National Cancer Center Hospital, Tokyo, Japan (T.S.). 28. National Hospital Organization Kyushu Medical Center, Fukuoka, Japan (N.H.). 29. Cancer Institute Hospital, Tokyo, Japan (A.C.). 30. Kyoto Prefectural University of Medicine, Osaka, Japan (H.I.). 31. The University of Tokyo, Tokyo, Japan (M.N.). 32. National Hospital Organization Tokyo Medical Center, Tokyo, Japan (T.U.).
Abstract
Background: Management of anticoagulants for patients undergoing polypectomy is still controversial. Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP). Objective: To compare outcomes between continuous administration of anticoagulants (CA) with CSP (CA+CSP) and periprocedural heparin bridging (HB) with HSP (HB+HSP) for subcentimeter colorectal polyps. Design: Multicenter, parallel, noninferiority randomized controlled trial. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000019355). Setting: 30 Japanese institutions. Patients: Patients receivinganticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp. Intervention: Patients were randomly assigned to undergo HB+HSP or CA+CSP and followed up 28 days after polypectomy. Measurements: The primary end point was incidence of polypectomy-related major bleeding (based on the incidence of poorly controlled intraprocedural bleeding or postpolypectomy bleeding requiring endoscopic hemostasis). The prespecified inferiority margin was -5% (CA+CSP vs. HB+HSP). Results: A total of 184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment. The incidence of polypectomy-related major bleeding in the HB+HSP and CA+CSP groups was 12.0% (95% CI, 5.0% to 19.1%) and 4.7% (CI, 0.2% to 9.2%), respectively. The intergroup difference for the primary end point was +7.3% (CI, -1.0% to 15.7%), with a 0.4% lower limit of 2-sided 90% CI, demonstrating the noninferiority of CA+CSP. The mean procedure time for each polyp and the hospitalization period were longer in the HB+HSP than in the CA+CSP group. Limitation: An open-label trial assessing 2 factors (anticoagulation approach and polypectomy procedure type) simultaneously. Conclusion:Patients having CA+CSP for subcentimeter colorectal polyps who were receiving oral anticoagulants did not have an increased incidence of polypectomy-related major bleeding, and procedure time and hospitalization were shorter than in those having HB+HSP. Primary Funding Source: Japanese Gastroenterological Association.
RCT Entities:
Background: Management of anticoagulants for patients undergoing polypectomy is still controversial. Cold snare polypectomy (CSP) is reported to cause less bleeding than hot snare polypectomy (HSP). Objective: To compare outcomes between continuous administration of anticoagulants (CA) with CSP (CA+CSP) and periprocedural heparin bridging (HB) with HSP (HB+HSP) for subcentimeter colorectal polyps. Design: Multicenter, parallel, noninferiority randomized controlled trial. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000019355). Setting: 30 Japanese institutions. Patients: Patients receiving anticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp. Intervention: Patients were randomly assigned to undergo HB+HSP or CA+CSP and followed up 28 days after polypectomy. Measurements: The primary end point was incidence of polypectomy-related major bleeding (based on the incidence of poorly controlled intraprocedural bleeding or postpolypectomy bleeding requiring endoscopic hemostasis). The prespecified inferiority margin was -5% (CA+CSP vs. HB+HSP). Results: A total of 184 patients were enrolled: 90 in the HB+HSP group, 92 in the CA+CSP group, and 2 who declined to participate after enrollment. The incidence of polypectomy-related major bleeding in the HB+HSP and CA+CSP groups was 12.0% (95% CI, 5.0% to 19.1%) and 4.7% (CI, 0.2% to 9.2%), respectively. The intergroup difference for the primary end point was +7.3% (CI, -1.0% to 15.7%), with a 0.4% lower limit of 2-sided 90% CI, demonstrating the noninferiority of CA+CSP. The mean procedure time for each polyp and the hospitalization period were longer in the HB+HSP than in the CA+CSP group. Limitation: An open-label trial assessing 2 factors (anticoagulation approach and polypectomy procedure type) simultaneously. Conclusion:Patients having CA+CSP for subcentimeter colorectal polyps who were receiving oral anticoagulants did not have an increased incidence of polypectomy-related major bleeding, and procedure time and hospitalization were shorter than in those having HB+HSP. Primary Funding Source: Japanese Gastroenterological Association.
Authors: Neena S Abraham; Alan N Barkun; Bryan G Sauer; James Douketis; Loren Laine; Peter A Noseworthy; Jennifer J Telford; Grigorios I Leontiadis Journal: J Can Assoc Gastroenterol Date: 2022-03-17
Authors: Vinay Chandrasekhara; Nikhil A Kumta; Barham K Abu Dayyeh; Manoop S Bhutani; Pichamol Jirapinyo; Kumar Krishnan; John T Maple; Joshua Melson; Rahul Pannala; Mansour A Parsi; Amrita Sethi; Guru Trikudanathan; Arvind J Trindade; David R Lichtenstein Journal: VideoGIE Date: 2021-04-02
Authors: Andrew M Veitch; Franco Radaelli; Raza Alikhan; Jean-Marc Dumonceau; Diane Eaton; Jo Jerrome; Will Lester; David Nylander; Mo Thoufeeq; Geoffroy Vanbiervliet; James R Wilkinson; Jeanin E van Hooft Journal: Endoscopy Date: 2021-08-06 Impact factor: 10.093
Authors: Andrew M Veitch; Franco Radaelli; Raza Alikhan; Jean Marc Dumonceau; Diane Eaton; Jo Jerrome; Will Lester; David Nylander; Mo Thoufeeq; Geoffroy Vanbiervliet; James R Wilkinson; Jeanin E Van Hooft Journal: Gut Date: 2021-09 Impact factor: 23.059