Yoji Takeuchi, MD; Katsuhiro Mabe, MD, PhD; Yuichi Shimodate, MD; Shinji Yoshii, MD, PhD; Shinya Yamada, MD; Mineo Iwatate, MD, PhD; Takuji Kawamura, MD, PhD; Kinichi Hotta, MD; Koji Nagaike, MD; Nobuaki Ikezawa, MD; Tomoaki Yamasaki, MD; Yoriaki Komeda, MD, PhD; Satoshi Asai, MD; Yasuhiro Abe, MD; Takuji Akamatsu, MD, PhD; Yuko Sakakibara, MD; Hisatomo Ikehara, MD, PhD; Yuzuru Kinjo, MD; Takashi Ohta, MD; Yoko Kitamura, MD; Takashi Shono, MD, PhD; Takuya Inoue, MD, PhD; Yoshio Ohda, MD, PhD; Nozomu Kobayashi, MD; Tokuma Tanuma, MD, PhD; Ryu Sato, MD; Taku Sakamoto, MD, PhD; Naohiko Harada, MD, PhD; Akiko Chino, MD, PhD; Hideki Ishikawa, MD, PhD; Masanori Nojima, MD, PhD, MPH; Toshio Uraoka, MD, PhD; for the Madowazu Study Group *
Acknowledgment: The authors thank Ms. Atsuko Michishita (Medical Research Support) for data management, the members of the Madowazu Study Group (listed in Appendix 1) for their participation, the members of the Efficacy and Safety Assessment Committee (Dr. Shigeaki Yoshida, Dr. Takuji Gotoda, Dr. Eriko Nakamura, and Dr. Atsushi Imagawa) for their contribution, and the members of the Japanese Gastroenterological Association (Chairperson, Prof. Kazuhide Higuchi) for their support.
Grant Support: By the Japanese Gastroenterological Association.
Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-0026.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Catharine B. Stack, PhD, MS, Deputy Editor, Statistics, reports that she has stock holdings in Pfizer, Johnson & Johnson, and Colgate-Palmolive. Christina C. Wee, MD, MPH, Deputy Editor, reports employment with Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Yu-Xiao Yang, MD, MSCE, Deputy Editor, reports that he has no financial relationships or interest to disclose.
Data Sharing Statement: The following data will be made available with publication: complete deidentified patient data set (contact Yoji Takeuchi; e-mail, email@example.com or firstname.lastname@example.org). The following supporting documents will be made available with publication: analytic/statistical code (contact Yoji Takeuchi; e-mail, email@example.com or firstname.lastname@example.org). These data will be made available for any purpose to researchers whose proposed use of the data has been approved.
Corresponding Author: Yoji Takeuchi, MD, Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan; e-mail, email@example.com or firstname.lastname@example.org.
Current Author Addresses: Dr. Takeuchi: Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan.
Dr. Mabe: National Hospital Organization Hakodate National Hospital, 18-16 Kawahara, Hakodate, 041-8512, Japan.
Dr. Shimodate: Kurashiki Central Hospital, 1-1-1, Miwa, Kurashiki, Okayama, 710-8602, Japan.
Dr. Yoshii: Sapporo Medical Center NTT EC, S1 W15, Chuo-ku, Sapporo 060-0061, Japan.
Dr. Yamada: Kanazawa University Hospital, 920-8641 13-1 Takara-machi Kanazawa Ishikawa, Japan.
Dr. Iwatate: Sano Hospital, 2-5-1, Shimizugaoka, Tarumi-ku, Kobe, Hyogo, 655-0031, Japan.
Dr. Kawamura: Kyoto Second Red Cross Hospital, 355-5, Haruobi-cho, Kamigyo-ku, Kyoto 602-8026, Japan.
Dr. Hotta: Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
Dr. Nagaike: Suita Municipal Hospital, 5-7 Kishibeshinmachi, Suita, Osaka 564-8567, Japan.
Dr. Ikezawa: Kobe University, Department of Gastroenterology, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan.
Dr. Yamasaki: Department of Gastroenterology, Osaka City General Hospital, 2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka, 534-0021, Japan.
Dr. Komeda: Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511 Japan.
Dr. Asai: Tane General Hospital, 1-12-21 Kujominami Nishiku Osaka, 550-0025, Japan.
Dr. Abe: Hanyu General Hospital, 446 Shimoiwase, Hanyu-shi, Saitama, 348-8505, Japan.
Dr. Akamatsu: Japanese Red Cross Society Wakayama Medical Center, 4-20, Komatsubara-dori, Wakayama-city, Wakayama, 6408558, Japan.
Dr. Sakakibara: National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.
Dr. Ikehara: Nihon University School of Medicine, 1-6 Surugadai, Kanda, Chiyoda-ku, Tokyo, 101-8309, Japan.
Dr. Kinjo: Naha City Hospital, 2-31-1 Furujima, Naha-city, Okinawa, 902-8511, Japan.
Dr. Ohta: Kansai Rosai Hospital, 3-1-69, Inabasou, Amagasaki, Hyogo, Japan.
Dr. Kitamura: Nara City Hospital, 1-50-1 Kidera-cho, Nara city, Nara, 630-8305, Japan.
Dr. Shono: Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
Dr. Inoue: Osaka General Medical Center, 3-1-56, Bandai-higashi, Sumiyoshi-ku, Osaka-city, Japan.
Dr. Ohda: Nara Endoscopic Clinic, 9-1-1 Sanjohonmachi, Nara 630-8122, Japan.
Dr. Kobayashi: Tochigi Cancer Center, 4-9-13 Yonan, Utsunomiya, Tochigi, Japan.
Dr. Tanuma: Teine Keijinkai Hospital, 1-12 Maeda, Teine-ku, Sapporo 006-8555, Japan.
Dr. Sato: Sakaemachi Gastroenterogical Endoscopic Clinic, 15 Chome-2-15 Kita 40 Johigashi, Higashi-ku, Sapporo-shi, Hokkaido 007-0840, Japan.
Dr. Sakamoto: National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Dr. Harada: National Hospital Organization Kyushu Medical Center, 1-8-1 Jigyohama, Chuo-ku, Fukuoka 810-8563, Japan.
Dr. Chino: Cancer Institute Ariake Hospital of Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku Tokyo 135-8550, Japan.
Dr. Ishikawa: Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 3-2-17-2F Imabashi, Chuo-ku, Osaka 541-0042, Japan.
Dr. Nojima: The Institute of Medical Science Hospital, The University of Tokyo, 4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan.
Dr. Uraoka: Gunma University Graduate School of Medicine, 3-39-22, Showa-machi, Maebashi, Gunma, 371-8514, Japan.
Author Contributions: Conception and design: Y. Takeuchi, K. Mabe, S. Yoshii, S. Yamada, M. Iwatate, K. Hotta, H. Ishikawa, M. Nojima, T. Uraoka.
Analysis and interpretation of the data: Y. Takeuchi, S. Yamada, K. Hotta, M. Nojima.
Drafting of the article: Y. Takeuchi, K. Mabe, K. Hotta, M. Nojima.
Critical revision for important intellectual content: K. Mabe, S. Yoshii, T. Kawamura, T. Akamatsu.
Final approval of the article: Y. Takeuchi, K. Mabe, Y. Shimodate, S. Yoshii, S. Yamada, M. Iwatate, T. Kawamura, K. Hotta, K. Nagaike, N. Ikezawa, T. Yamasaki, Y. Komeda, S. Asai, Y. Abe, T. Akamatsu, Y. Sakakibara, H. Ikehara, Y. Kinjo, T. Ohta, Y. Kitamura, T. Shono, T. Inoue, Y. Ohda, N. Kobayashi, T. Tanuma, R. Sato, T. Sakamoto, N. Harada, A. Chino, H. Ishikawa, M. Nojima, T. Uraoka.
Provision of study materials or patients: S. Yamada, K. Nagaike, N. Ikezawa, S. Asai, Y. Abe, T. Ohta, Y. Ohda, N. Kobayashi.
Statistical expertise: M. Nojima.
Obtaining of funding: Y. Takeuchi, S. Yoshii.
Administrative, technical, or logistic support: Y. Takeuchi, K. Hotta, H. Ishikawa, M. Nojima.
Collection and assembly of data: Y. Shimodate, S. Yoshii, T. Kawamura, K. Hotta, N. Ikezawa, T. Yamasaki, Y. Komeda, Y. Abe, T. Akamatsu, Y. Sakakibara, H. Ikehara, Y. Kinjo, T. Ohta, Y. Kitamura, T. Shono, T. Inoue, T. Tanuma, R. Sato, T. Sakamoto, N. Harada, A. Chino, H. Ishikawa, T. Uraoka.
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).
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.
Multicenter, parallel, noninferiority randomized controlled trial. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000019355)
30 Japanese institutions.
Patients receiving anticoagulant therapy (warfarin or direct oral anticoagulants) who had at least 1 nonpedunculated subcentimeter colorectal polyp.
Patients were randomly assigned to undergo HB+HSP or CA+CSP and followed up 28 days after polypectomy.
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).
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.
An open-label trial assessing 2 factors (anticoagulation approach and polypectomy procedure type) simultaneously.
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.
Japanese Gastroenterological Association.
Takeuchi Y, Mabe K, Shimodate Y, et al, for the Madowazu Study Group. Continuous Anticoagulation and Cold Snare Polypectomy Versus Heparin Bridging and Hot Snare Polypectomy in Patients on Anticoagulants With Subcentimeter Polyps: A Randomized Controlled Trial. Ann Intern Med. 2019;171:229–237. [Epub ahead of print 16 July 2019]. doi: https://doi.org/10.7326/M19-0026
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Published: Ann Intern Med. 2019;171(4):229-237.
Published at www.annals.org on 16 July 2019
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