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Randomized controlled trial of endoscopic closure vs. non-closure after colon ESD for preventing post-ESD coagulation syndrome and delayed perforation

Randomized controlled trial of endoscopic closure vs. non-closure after colon ESD for preventing post-ESD coagulation syndrome and delayed perforation - CliPEC study (endoscopic Clipping closure for preventing Post-ESD Coagulation syndrome and delayed perforation)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027031
Enrollment
320
Registered
2017-04-18
Start date
2017-04-24
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 adenoma, early colorectal cancer

Interventions

Non-closure Endoscopic closure

Sponsors

Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Lead Sponsor
Nagoya City University Hospital, Nagoya City West Medical Center, Japanese Red Cross Nagoya Daini Hospital, Aichi Medical University Hospital, Gifu Prefectural Tajimi Hospital, Kasugai Municipal Hospital, Chukyo Hospital, Nagoya City East Medical Center, Nagoya Memorial Hospital, Toyokawa City Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Colorectal adenoma or eraly colorectal cancer =< 5cm that will be treated with ESD 2. Age from 20 to 85 years old 3. Agreement with signed informed consent

Exclusion criteria

Exclusion criteria: 1. Tumor size > 5cm 2. Cutting line will be into appendix, ileo-cecal valve or anus 3. Severe dysfunction of heart, lung and kidney 4. Poor status: Performance Status(ECOG) 3 or 4 5. VAS>20mm, BT>37.0(celsius) or WBC>normal range 6. Administration of steroid or pain killer 7. Administration of anti-cogulant drugs 8. Pregnancy 9. Metalic allergy 10. Inappropriateness with physician's judgement

Design outcomes

Primary

MeasureTime frame
The rate of PECS and delayed perforation—

Secondary

MeasureTime frame
The rate of PECS, delayed perforation, delayed bleeding and other complications. Success rate and treatment time of endoscopic closure. Elucidation for clinical features of PECS—

Countries

Japan

Contacts

Public ContactTakaya Shimura

Nagoya City University Graduate School of Medical Sciences Department of Gastroenterology and Metabolism

tshimura@med.nagoya-cu.ac.jp052-853-8211

Outcome results

None listed

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