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

データセット

説明

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
利用可能になった日2021
出版社figshare
  • Continuous warfarin administration versus heparin bridging therapy in post colorectal polypectomy haemorrhage: a study protocol for a multicentre randomised controlled trial (WHICH study)

    Nagami, Y., Sakai, T., Yamamura, M., Nakatani, M., Katsuno, T., Suekane, T., Uno, H., Minamino, H., Okuyama, M., Okamoto, J., Kumamoto, M., Noguchi, A., Yamamori, K., Takaishi, O., Ochi, M., Miyazaki, T., Tsuji, S., Ikehara, H., Kawaguchi, K. & Hayashi, T. & 36 others, Mannami, T., Kakimoto, K., Naito, Y., Hashimoto, S., Li, Z., Komeda, Y., Kishino, T., Yamamoto, Y., Iguchi, M., Akamatsu, T., Horii, T., Miura, K., Yamashina, T., Sugihara, Y., Watanabe, N., Kiyotoki, S., Fujii, R., Murata, M., Ono, S., Narasaka, T., Kitamura, S., Kono, M., Kato, M., Kawaratani, H., Tanaka, K., Yaoita, T., Yamaguchi, S., Abe, K., Kawamura, T., Kinoshita, Y., Imai, K., Fujinami, H., Yada, T., Miyamoto, H., Yoshida, H. & Fujiwara, Y., 2021/12, In: Trials. 22, 1, 33.

    研究成果: ジャーナルへの寄稿学術論文査読

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