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Effects of prophylactic clip closure versus non-closure after colorectal endoscopic submucosal dissection on postoperative outcomes: A phase III prospective randomized controlled trial

Effects of prophylactic clip closure versus non-closure after colorectal endoscopic submucosal dissection on postoperative outcomes: A phase III prospective randomized controlled trial - EPOC Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043675
Enrollment
300
Registered
2021-05-01
Start date
2021-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal neoplasm

Interventions

closure group non-closure group

Sponsors

Asahi General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Lesions for which en bloc resection with snare EMR is difficult to apply and tumor size is 20 to 50 mm (2) Aged above 20 years old (3) Performance status of 0, 1 or 2 (4) To obey the guidelines in patients undergoing antithrombotic treatment proposed by the Japan Gastroenterological Endoscopy Society (5) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Preoperative endoscopic diagnosis of tumor depth is cT1b(SM2) (2) Lesions of local recurrence after endoscopic resection (3) Familial adenomatous polyposis and inflammatory bowel disease (4) Patients with thrombocytopenia and/or bleeding tendency (5) Women during pregnancy (6) Unsuitable patient for clinical trial judged by clinicians

Design outcomes

Primary

MeasureTime frame
delayed bleeding rate (severe) delayed bleeding rate (mild)

Secondary

MeasureTime frame
delayed perforation rate Post-ESD coagulation syndrome rate clip closure time the number and type of clips for closure pathological findings procedure time resection speed en bloc resection rate complete resection rate curative resection rate the number of antithrombotic medicine users

Countries

Japan

Contacts

Public ContactAkihiro Miyakawa

Asahi General Hospital Department of Gastroenterology

a292miyaka2007@yahoo.co.jp+81479638111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026