Efficacy of prophylactic clip closure in reducing the risk of delayed bleeding after colorectal endoscopic submucosal dissection in patients on anticoagulant therapy: Multicenter prospective study

Ogiyama, Hideharu; Kato, Minoru; Yamaguchi, Shinjiro; Kanesaka, Takashi; Yamada, Takuya; Yamamoto, Masashi; Komori, Masato; Nagaike, Koji; Nakahara, Masanori; Tsutsui, Shusaku; Tsujii, Yoshiki; Saita, Ryotaro; Iijima, Hideki; Hayashi, Yoshito; Takehara, Tetsuo

doi:https://doi.org/10.1111/den.14761

Efficacy of prophylactic clip closure in reducing the risk of delayed bleeding after colorectal endoscopic submucosal dissection in patients on anticoagulant therapy: Multicenter prospective study

Ogiyama, Hideharu; Kato, Minoru; Yamaguchi, Shinjiro et al.

Digestive Endoscopy, 2024, 36(9), 1021-1029

Number of Access:2,020（2025-09-06 15:08 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/95267

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Title	Efficacy of prophylactic clip closure in reducing the risk of delayed bleeding after colorectal endoscopic submucosal dissection in patients on anticoagulant therapy: Multicenter prospective study
Creator	CreatorName Ogiyama, Hideharu
	NRID 1000080939249 1000080939249 CreatorName Kato, Minoru
	CreatorName Yamaguchi, Shinjiro
	CreatorName Kanesaka, Takashi
	CreatorName Yamada, Takuya
	CreatorName Yamamoto, Masashi
	CreatorName Komori, Masato
	CreatorName Nagaike, Koji
	CreatorName Nakahara, Masanori
	NRID 1000010359846 1000010359846 CreatorName Tsutsui, Shusaku
	NRID 1000080795170 1000080795170 researchmap permalink yhcks yhcks Scopus Author ID 57192176408 57192176408 CreatorName Tsujii, Yoshiki
	NRID 1000000911736 1000000911736 CreatorName Saita, Ryotaro
	NRID 1000090444520 1000090444520 researchmap permalink _0719 _0719 CreatorName Iijima, Hideki
	NRID 1000080647123 1000080647123 researchmap permalink y-h y-h Scopus Author ID 35219993200 35219993200 CreatorName Hayashi, Yoshito
	NRID 1000070335355 1000070335355 researchmap permalink takeharatetsuo takeharatetsuo Scopus Author ID 7103332258 7103332258 CreatorName Takehara, Tetsuo
Subject	anticoagulant therapy
	antithrombotic drug
	colorectal endoscopic submucosal dissection
	delayed bleeding
	prophylactic clip closure
Description	Ogiyama H., Kato M., Yamaguchi S., et al. Efficacy of prophylactic clip closure in reducing the risk of delayed bleeding after colorectal endoscopic submucosal dissection in patients on anticoagulant therapy: Multicenter prospective study. Digestive Endoscopy , (2024); https://doi.org/10.1111/den.14761.
Abstract	Objectives: The high rate of delayed bleeding after colorectal endoscopic submucosal dissection (ESD) in patients undergoing anticoagulant therapy remains a problem. Whether prophylactic clip closure reduces the rate of delayed bleeding in these patients is unclear. This study aimed to evaluate the efficacy of prophylactic clip closure in patients receiving anticoagulants. Methods: This multicenter prospective interventional trial was conducted at nine referral centers in Japan. Patients regularly taking anticoagulants, including warfarin potassium or direct oral anticoagulants, and undergoing ESD for colorectal neoplasms were enrolled. The discontinuation of anticoagulants was minimized according to recent guidelines. After the ESD, post-ESD ulcers were prophylactically closed using endoclips. The primary end-point was the incidence of delayed bleeding. The sample size was 45 lesions, and prophylactic clip closure was considered effective when the upper limit of the 90% confidence interval (CI) for delayed bleeding did not exceed 20%. Results: Forty-five lesions were used, and three were excluded. Complete closure was achieved in 41/42 lesions (97.6%). The overall delayed bleeding rate was low, at 4.9% (2/41; 90% [CI] 0.8–14.5), which was significantly lower than that at the prespecified threshold of 20% (P = 0.007). The median closure procedure time was 17 min, and the median number of clips was nine. No massive delayed bleeding requiring transfusion, interventional radiology, or surgery was observed, and no thromboembolic events were observed. Conclusion: Prophylactic clip closure may reduce the risk of delayed bleeding following colorectal ESD in patients receiving anticoagulants. Trial registration: UMIN Clinical Trial Registry (UMIN000036734).
Publisher	John Wiley and Sons Inc
Source Title	Digestive Endoscopy
Volume (Issue)	36(9)
Page	1021-1029
Date of Issued	2024-02-20
Language	English
Handle URL	https://hdl.handle.net/11094/95267
PISSN	09155635
eISSN	14431661
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.1111/den.14761
Access Rights	open access
CopyRight	This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
oaire:version	Version of Record
Category	学術雑誌論文 Journal Article

Resource Type	journal article
Local Type	Journal Article
DCMI Type	Text
DCTERMS.bibliographicCitation	Digestive Endoscopy. 2024, 36(9), p. 1021-1029
DC.title	Efficacy of prophylactic clip closure in reducing the risk of delayed bleeding after colorectal endoscopic submucosal dissection in patients on anticoagulant therapy: Multicenter prospective study
DC.creator	Ogiyama, Hideharu
	Kato, Minoru
	Yamaguchi, Shinjiro
	Kanesaka, Takashi
	Yamada, Takuya
	Yamamoto, Masashi
	Komori, Masato
	Nagaike, Koji
	Nakahara, Masanori
	Tsutsui, Shusaku
	Tsujii, Yoshiki
	Saita, Ryotaro
	Iijima, Hideki
	Hayashi, Yoshito
	Takehara, Tetsuo
DC.publisher	John Wiley and Sons Inc
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2024-02-20
DC.identifier	https://doi.org/10.1111/den.14761
DC.subject	anticoagulant therapy
	antithrombotic drug
	colorectal endoscopic submucosal dissection
	delayed bleeding
	prophylactic clip closure
DC.description	Ogiyama H., Kato M., Yamaguchi S., et al. Efficacy of prophylactic clip closure in reducing the risk of delayed bleeding after colorectal endoscopic submucosal dissection in patients on anticoagulant therapy: Multicenter prospective study. Digestive Endoscopy , (2024); https://doi.org/10.1111/den.14761.
DCTERMS.abstract	Objectives: The high rate of delayed bleeding after colorectal endoscopic submucosal dissection (ESD) in patients undergoing anticoagulant therapy remains a problem. Whether prophylactic clip closure reduces the rate of delayed bleeding in these patients is unclear. This study aimed to evaluate the efficacy of prophylactic clip closure in patients receiving anticoagulants. Methods: This multicenter prospective interventional trial was conducted at nine referral centers in Japan. Patients regularly taking anticoagulants, including warfarin potassium or direct oral anticoagulants, and undergoing ESD for colorectal neoplasms were enrolled. The discontinuation of anticoagulants was minimized according to recent guidelines. After the ESD, post-ESD ulcers were prophylactically closed using endoclips. The primary end-point was the incidence of delayed bleeding. The sample size was 45 lesions, and prophylactic clip closure was considered effective when the upper limit of the 90% confidence interval (CI) for delayed bleeding did not exceed 20%. Results: Forty-five lesions were used, and three were excluded. Complete closure was achieved in 41/42 lesions (97.6%). The overall delayed bleeding rate was low, at 4.9% (2/41; 90% [CI] 0.8–14.5), which was significantly lower than that at the prespecified threshold of 20% (P = 0.007). The median closure procedure time was 17 min, and the median number of clips was nine. No massive delayed bleeding requiring transfusion, interventional radiology, or surgery was observed, and no thromboembolic events were observed. Conclusion: Prophylactic clip closure may reduce the risk of delayed bleeding following colorectal ESD in patients receiving anticoagulants. Trial registration: UMIN Clinical Trial Registry (UMIN000036734).
DC.rights	This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
DC.format	95267
citation_title	Efficacy of prophylactic clip closure in reducing the risk of delayed bleeding after colorectal endoscopic submucosal dissection in patients on anticoagulant therapy: Multicenter prospective study
citation_author	Ogiyama, Hideharu
	Kato, Minoru
	Yamaguchi, Shinjiro
	Kanesaka, Takashi
	Yamada, Takuya
	Yamamoto, Masashi
	Komori, Masato
	Nagaike, Koji
	Nakahara, Masanori
	Tsutsui, Shusaku
	Tsujii, Yoshiki
	Saita, Ryotaro
	Iijima, Hideki
	Hayashi, Yoshito
	Takehara, Tetsuo
citation_publisher	John Wiley and Sons Inc
citation_language	English
citation_date	2024-02-20
citation_journal_title	Digestive Endoscopy
citation_volume	36
citation_issue	9
citation_firstpage	1021
citation_lastpage	1029
citation_doi	https://doi.org/10.1111/den.14761
citation_public_url	https://hdl.handle.net/11094/95267

Efficacy of prophylactic clip closure in reducing the risk of delayed bleeding after colorectal endoscopic submucosal dissection in patients on anticoagulant therapy: Multicenter prospective study

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