NCT02217085CompletedNot Applicable
Determining True Colorectal Polyp Resection Adequacy: Correlation of Endoscopic Margins With Histopathologic Margins
Rush University Medical Center1 site in 1 country288 target enrollmentStarted: May 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 288
- Locations
- 1
- Primary Endpoint
- The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins).
Study Overview
Brief Summary
The purpose of this study is to determine the best way to ensure that polyps are completely removed by evaluating the borders of the removed polyp. If a polyp is found that meets the size requirements for the study, the investigators will take extra biopsies of the margin to determine if there is any abnormal tissue or cancer at these borders.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 40-80
Exclusion Criteria
- •Coagulopathy (international normalized ratio >2)
- •Inflammatory bowel disease or other active colitides
- •Polyps of index colonoscopy that were felt not to be completely resected or pedunculated
- •Familial adenomatous polyposis or hereditary polyposis
- •Potential hereditary cancer syndrome (Lynch Syndrome)
Outcomes
Primary Outcomes
The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins).
Time Frame: Between 3-6 months
Define the frequency of free margins versus margins that have dysplasia to the cautery site in snare polypectomy. A free margin is defined as uninvolved or normal mucosa extending to the cautery margin at the polypectomy stalk.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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