Continuous warfarin administration versus heparin bridging therapy in post colorectal polypectomy haemorrhage: a study protocol for a multicentre randomised controlled trial (WHICH study)

Yasuaki Nagami, Taishi Sakai, Masafumi Yamamura, Masami Nakatani, Takayuki Katsuno, Takehisa Suekane, Hironori Uno, Hiroaki Minamino, Masatsugu Okuyama, Junichi Okamoto, Mitsutaka Kumamoto, Atsushi Noguchi, Kazuki Yamamori, Osamu Takaishi, Masahiro Ochi, Takako Miyazaki, Shigetsugu Tsuji, Hisatomo Ikehara, Koichiro Kawaguchi, Tomoyuki HayashiTomohiko Mannami, Kazuki Kakimoto, Yoshihide Naito, Satoru Hashimoto, Zhaoliang Li, Yoriaki Komeda, Takaaki Kishino, Yoshinobu Yamamoto, Mikitaka Iguchi, Takuji Akamatsu, Toshiki Horii, Ko Miura, Takeshi Yamashina, Yuusaku Sugihara, Noboru Watanabe, Shu Kiyotoki, Ryoji Fujii, Masaki Murata, Satoshi Ono, Toshiaki Narasaka, Shinji Kitamura, Mitsuhiro Kono, Motohiko Kato, Hideto Kawaratani, Kyosuke Tanaka, Takao Yaoita, Shinjiro Yamaguchi, Keiichiro Abe, Takuji Kawamura, Yosuke Kinoshita, Kenichiro Imai, Haruka Fujinami, Tomoyuki Yada, Hayato Miyamoto, Hisako Yoshida, Yasuhiro Fujiwara

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Abstract

Background: Endoscopic removal of colorectal adenoma is considered an effective treatment for reducing the mortality rates associated with colorectal cancer. Warfarin, a type of anticoagulant, is widely used for the treatment and prevention of thromboembolism; however, bleeding may increase with its administration after polypectomy. In recent times, a high incidence of bleeding after endoscopic polypectomy has been reported in patients receiving heparin bridge therapy. However, previous studies have not compared the bleeding rate after endoscopic colorectal polypectomy between patients who continued with anticoagulant therapy and those who received heparin bridge therapy. We hypothesised that endoscopic colorectal polypectomy under the novel treatment with continuous warfarin is not inferior to endoscopic colorectal polypectomy under standard treatment with heparin bridge therapy with respect to the rate of postoperative bleeding. This study aims to compare the efficacy of endoscopic colorectal polypectomy with continuous warfarin administration and endoscopic colorectal polypectomy with heparin bridge therapy with respect to the rate of postoperative bleeding. Methods: We will conduct a prospective multicentre randomised controlled non-inferiority trial of two parallel groups. We will compare patients scheduled to undergo colorectal polypectomy under anticoagulant therapy with warfarin. There will be 2 groups, namely, a standard treatment group (heparin bridge therapy) and the experimental treatment group (continued anticoagulant therapy). The primary outcome measure is the rate of postoperative bleeding. On the contrary, the secondary outcomes include the rate of cumulative bleeding, rate of overt haemorrhage (that does not qualify for the definition of haemorrhage after endoscopic polypectomy), incidence of haemorrhage requiring haemostasis during endoscopic polypectomy, intraoperative bleeding during endoscopic colorectal polypectomy requiring angiography, abdominal surgery and/or blood transfusion, total rate of bleeding, risk factors for postoperative bleeding, length of hospital stay, incidence of thromboembolism, prothrombin time-international ratio (PT-INR) 28 days after the surgery, and incidence of serious adverse events. Discussion: The results of this randomised controlled trial will provide valuable information for the standardisation of management of anticoagulants in patients scheduled to undergo colorectal polypectomy. Trial registration: UMIN-CTR UMIN000023720. Registered on 22 August 2016

Original languageEnglish
Article number33
JournalTrials
Volume22
Issue number1
DOIs
Publication statusPublished - 2021 Dec

Keywords

  • Anticoagulants
  • Colorectal polypectomy
  • Heparin bridge
  • Vitamin K antagonist
  • Warfarin

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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