Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps
1 other identifier
interventional
238
1 country
1
Brief Summary
Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Preventive methods such as endoloop and epinephrine injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no randomized controlled study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So the investigators designed a randomized controlled trial to confirm the efficacy of application of prophylactic clip in the prevention of postpolypectomy bleeding in large polyps.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 3, 2014
CompletedFirst Posted
Study publicly available on registry
June 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedJanuary 27, 2020
January 1, 2020
3.9 years
June 3, 2014
January 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Postpolypectomy bleeding
Immediate and delayed postpolypectomy bleeding
1 month
Study Arms (2)
Prophylactic clip
EXPERIMENTALBefore conventional snare polypectomy, hemoclips will be applied on the base of stalk.
No prophylactic management
ACTIVE COMPARATORConventional snare polypectomy will be performed without any preventive management.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.
You may not qualify if:
- bleeding tendency, poor preparation, sessile polyp
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Incheon St. Mary's Hospital, The Catholic University of Korea
Incheon, South Korea
Related Publications (1)
Gweon TG, Lee KM, Lee SW, Kim DB, Ji JS, Lee JM, Chung WC, Paik CN, Choi H. Effect of prophylactic clip application for the prevention of postpolypectomy bleeding of large pedunculated colonic polyps: a randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):148-154. doi: 10.1016/j.gie.2020.12.040. Epub 2021 Jan 5.
PMID: 33417897DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong-Seon Ji, Dr
Incheon St. Mary's Hospital, The Catholic University of Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 3, 2014
First Posted
June 5, 2014
Study Start
June 1, 2014
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
January 27, 2020
Record last verified: 2020-01