Evidence map›Paper›PMID 40461060›Full record

Trial reportGut2025

Prophylactic clip closure after endoscopic submucosal dissection of large flat and sessile colorectal polyps: a multicentre randomised controlled trial (EPOC trial).

Akihiro Miyakawa, Yuzuru Tamaru, Takeshi Mizumoto, Noriyoshi Kanazawa, Shiori Uchiyama, Kosuke Maehara, Yorinobu Sumida, Akira Nakamura, Ei Itobayashi, Haruhisa Shimura and 4 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Gut, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Hybrid endoscopic submucosal dissection-endoscopic mucosal resection of large polyps at the ileocecal valve.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2026
    Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Akihiro Miyakawa *Department of Gastroenterology, Asahi General Hospital, Asahi, Japan a292miyaka2007@yahoo.co.jp kuwai@hiroshima-u.ac.jp.ORCID 0000-0002-5872-0516
Yuzuru TamaruDepartment of Endoscopy, NHO Kure Medical Center and Chugoku Cancer Center, Kure, Japan.
Takeshi MizumotoDepartment of Endoscopy, NHO Kure Medical Center and Chugoku Cancer Center, Kure, Japan.
Noriyoshi KanazawaDepartment of Gastroenterology, Yokohama Rosai Hospital, Yokohama, Japan.
Shiori UchiyamaDepartment of Gastroenterology, Yokohama Rosai Hospital, Yokohama, Japan.
Kosuke MaeharaDepartment of Gastroenterology, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.
Yorinobu SumidaDepartment of Gastroenterology, Kitakyushu Municipal Medical Center, Kitakyushu, Japan.
Akira NakamuraDepartment of Gastroenterology, Asahi General Hospital, Asahi, Japan.
Ei ItobayashiDepartment of Gastroenterology, Asahi General Hospital, Asahi, Japan.
Haruhisa ShimuraDepartment of Gastroenterology, Asahi General Hospital, Asahi, Japan.
Yoshio SuzukiDepartment of Pathology, Asahi General Hospital, Asahi, Japan.
Tomoyuki AkitaDepartment of Epidemiology, Infectious Disease Control, and Prevention, Institute of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Kenji ShimuraDepartment of Gastroenterology, Asahi General Hospital, Asahi, Japan.
Toshio Kuwai *Department of Endoscopy, NHO Kure Medical Center and Chugoku Cancer Center, Kure, Japan a292miyaka2007@yahoo.co.jp kuwai@hiroshima-u.ac.jp.ORCID 0000-0001-9956-1358

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProphylactic clip closure after endoscopic mucosal resection reduces delayed bleeding in large and proximal colon lesions; however, evidence regarding its effectiveness in colorectal endoscopic submucosal dissection (ESD) is lacking.

objectiveTo compare clinically significant delayed bleeding rates between a clip closure and a control group for flat and sessile 20-50 mm colorectal polyps following ESD.

designA multicentre randomised controlled trial conducted at four Japanese institutions randomly assigned patients to closure or non-closure groups. Significant postprocedural bleeding (haematochezia) was classified as severe (requiring endoscopic haemostasis or blood transfusion in patients with haemoglobin levels <70 g/L or haemorrhagic shock) or mild.

resultsThe closure and control groups comprised 150 and 149 cases in the intention-to-treat (ITT) analysis and 142 and 141 cases in the per-protocol (PP) analysis, respectively. Rates of complete clip closure were 88.7% (ITT) and 93.0% (PP). The ITT analysis revealed delayed bleeding rates of 6.7% and 20.1% (OR: 0.28; 95% CI: 0.13 to 0.60; p<0.001; absolute risk difference (ARD): 13.5%; 95% CI: 5.6% to 20.9%) and severe delayed bleeding rates of 1.3% and 8.7% (OR: 0.14; 95% CI: 0.03 to 0.64; p=0.003; ARD: 7.4%; 95% CI: 2.2% to 12.4%) in the closure and control groups, respectively. These differences were confirmed in the PP analysis. Delayed perforation was not observed, and the post-ESD coagulation syndrome rate was not significantly different between the two groups. Multivariate logistic regression analyses identified prophylactic clip closure as a significant independent preventive factor for both delayed bleeding (OR: 0.22; 95% CI: 0.08 to 0.50; p<0.001) and severe delayed bleeding (OR: 0.22; 95% CI: 0.05 to 0.76; p=0.015).

conclusionsProphylactic clip closure, successfully achieved in approximately 90% of cases, reduced the delayed bleeding rate after resection of colorectal polyps measuring 20-50 mm. TRIAL REGISTRATION NUMBER: UMIN000043675.

Indexed as

Colonic PolypsColonoscopyEndoscopic Mucosal ResectionGastrointestinal HemorrhagePostoperative HemorrhageAgedAged, 80 and overFemaleHumansMaleMiddle AgedSurgical InstrumentsTreatment OutcomeBLEEDINGCOLONIC POLYPSENDOSCOPIC POLYPECTOMYENDOSCOPIC PROCEDURESENDOSCOPIC SUBMUCOSAL DISSECTIONENDOSCOPYPROPHYLACTIC CLIP CLOSURE

Identifiers

PMID40461060
PMCPMC12573426

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.