Polyp Resection Adequacy Clinical Trial
Official title:
Determining True Colorectal Polyp Resection Adequacy: Correlation of Endoscopic Margins With Histopathologic Margins
| NCT number | NCT02217085 |
| Other study ID # | RSA-RTSC 2014 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2014 |
| Est. completion date | June 30, 2022 |
| Verified date | August 2022 |
| Source | Rush University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 288 |
| Est. completion date | June 30, 2022 |
| Est. primary completion date | June 30, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 40 Years to 80 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Rush University Medical Center | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Rush University Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The incomplete resection rates in polyps from Group 1 (clear margins) versus Group 2 (positive margins). | 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. | Between 3-6 months |