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Spots Global Cancer Trial Database for Underwater Resection of Non-pedunculated Colorectal Lesions

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Trial Identification

Brief Title: Underwater Resection of Non-pedunculated Colorectal Lesions

Official Title: Underwater Resection of Non-pedunculated Colorectal Lesions: A Randomized Controlled Trial

Study ID: NCT02889679

Study Description

Brief Summary: The aim of this study is to compare the efficacy of underwater resection (polypectomy) versus conventional polypectomy techniques for small and large colorectal lesions identified during colonoscopy.

Detailed Description: Conventional endoscopic resection of small and large (≥1cm) colorectal lesions is well established and performed with the colon fully distended with gas. Conventional polypectomy is effective, but the rate of incomplete resection is approximately 10%. Incomplete eradication of precancerous lesions contributes to interval colorectal cancer; therefore, alternative techniques for resection that safely and effectively increase the rate of complete resection are important. Underwater resection (UR) of benign colorectal lesions is a novel technique that utilizes the advantages of water aided endoscopic methods and may decrease the incomplete resection rate of small and large non-pedunculated lesions. The investigators propose the hypothesis that small (6-9mm) and large (≥1cm) non-pedunculated neoplastic colorectal lesions resected by UR (partially distended, water filled lumen without submucosal fluid injection), will significantly decrease the incomplete resection rate (IRR) compared to conventional polypectomy performed in a gas distended lumen. Small (6-9mm) and large (≥1cm) non-pedunculated benign neoplastic colorectal lesions identified during screening, surveillance, diagnostic or therapeutic colonoscopy will be randomized to conventional polypectomy (in a gas distended lumen with or without submucosal fluid injection) versus UR (partially distended, water filled lumen without submucosal injection) at the patient level. Small (6-9mm) lesions will be removed with a 9mm firm, thin wire cold snare and large (≥1cm) lesions will be removed by snare electrocautery. Efforts to remove lesions en bloc with a small rim of normal mucosa will be made, although some larger lesions (≥2cm) may require piecemeal resection. Submucosal fluid injection with a solution may be used with conventional techniques for large and/or flat lesions. Post-polypectomy incomplete resection rates will be assessed from 4 quadrant biopsies obtained around the resection site immediately post-resection.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sacramento VA Medical Center (VANCHCS), Mather, California, United States

Contact Details

Name: Andrew W Yen, MD

Affiliation: VA Northern California Health Care System

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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