Underwater Endoscopic Mucosal Resection

Launched by INSTITUTO PORTUGUES ONCOLOGIA DE LISBOA FRANCISCO GENTIL · Oct 4, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new method called Underwater Endoscopic Mucosal Resection (U-EMR) to help remove large polyps from the colon. Polyps are growths that can sometimes lead to cancer if not treated. The study aims to understand how well skilled doctors can perform this procedure in real-life situations, and to see how often they can completely remove the polyps and if there are any complications from the procedure.

To be eligible for this trial, participants need to be at least 18 years old and have one large non-pedunculated polyp (a polyp that is not attached by a stalk) that measures between 10 and 30 millimeters. Participants will need to agree to the study and sign a consent form before the procedure. If someone has had a previous attempt to remove a polyp or has certain types of polyps or other health conditions, they may not be able to join the study. Those who participate can expect to undergo the U-EMR procedure and will be monitored for how well it works and any side effects. This trial is currently recruiting participants of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: 18 years-old or older with at least one large (\>10 and \<30 mm) non pedunculated polyp
• • Agreement with study's procedures, having signed the informed consent for the study and EMR, prior to the procedure
• Exclusion Criteria:
• • Previous attempted resection
• • Lesion located at ileo-cecal valve or appendiceal orifice
• • Fully circumferential lesion
• • Pedunculated polyps (Paris classification type Ip) and ulcerated depression lesions (Paris classification type III)
• • Surface pattern suggestive of deep invasion (ex: narrow-band imaging (NBI) International Colorectal Endoscopic (NICE) classification type 3 criteria, Kudo V or equivalent)
• • Invasive cancer at EMR specimen
• • Inflammatory bowel disease
• • Familial polyposis syndrome