Cold Snare Polypectomy Versus. Endoscopic Mucosal Resection
Comparison of Efficacy Between Cold Snare Polypectomy and Endoscopic Mucosal Resection in Treatment of Small Polyp
1 other identifier
interventional
103
1 country
1
Brief Summary
The investigators will investigate the efficacy of EMR compared to CSP in treatment of small colon polp (6\~10mm). One aim of this study was to investigate the necessity of EMR on resection of small colon polyp.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 17, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJune 24, 2015
June 1, 2015
3 months
June 17, 2015
June 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete resection rate (CRR)
Up to 2 months
Secondary Outcomes (4)
incidence of complications (Intraprocedural bleeding, postprocedural bleeding, and perforation)
Up to 2 months
necessity of hemostasis (due to Intraprocedural bleeding or postprocedural bleeding)
Up to 2 months
Polyp retrieval rate
Up to 2 months
hospitalization period
Up to 2 months
Study Arms (2)
Cold snare polypectomy
EXPERIMENTALCSP will be performed by closing the snare loop after positioning the open snare at the point of lesion.
Endoscopic mucosal resection
ACTIVE COMPARATOREMR will be performed in the way of drawing the lesion into the loop of the snare and resecting followed by saline injection to the its margin.
Interventions
Eligibility Criteria
You may qualify if:
- All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm)
You may not qualify if:
- (1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, Seoul, 138-736, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jeong-Sik Byeon, Doctor
Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 17, 2015
First Posted
June 19, 2015
Study Start
June 1, 2015
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
June 24, 2015
Record last verified: 2015-06