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A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)

A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection) - A multicenter prospective study of the efficacy of prophylactic clip closure for prevention of delayed bleeding after colorectal ESD (endoscopic submucosal dissection)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000036734
Enrollment
45
Registered
2019-07-04
Start date
2019-06-11
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 neoplasms

Interventions

Prophylactic clip closure after colorectal ESD

Sponsors

Osaka University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with colorectal neoplasms considered an indication for colorectal ESD. 2)Lesions not larger than 50mm in diameter. 3)Allow multiple ESD and /or endoscopic resection other than ESD scheduled at the same time 4)Age 20 or older at registration. 5)Performance Status (ECOG) is 0, 1 or 2. 6)Receiving anticoagulant therapy. 7)Preserved major organs functions (bone marrow, liver, kidney, lung etc.). 8)Written informed consent from the patient himself.

Exclusion criteria

Exclusion criteria: 1)Lesions extending to the anal canal or ileocecal valve. 2)Have schedules to receive another endoscopic resection for colorectal neoplasms within 28 days after this ESD. 3)Have schedules to receive chemotherapy, radiation therapy or surgery within 28 days after this ESD. 4)Judged that registration or participation in this study is difficult due to a psychiatric disorder. 5)allergy to metal. 6)Otherwise determined by investigators to be unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
The rate of delayed bleeding after prophylactic clip closure

Secondary

MeasureTime frame
The severity of delayed bleeding Timing of delayed bleeding The rate of thromboembolism Closure time, The number of clips, The rate of lesions which cannot be closed The incidence rate of PECS Duration of hospitalization The rate of delayed perforation The rate of all adverse events The rate of adverse events associated with ESD

Countries

Japan

Contacts

Public ContactHideharu Ogiyama

Ikeda Municipal Hospital Department of Gastroenterology

hideharu-ogiyama@hosp.ikeda.osaka.jp072-751-2881

Outcome results

None listed

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