Assessing underwater endoscopic mucosal resection for colon polyps
Underwater Endoscopic Mucosal Resection a Learning Curve Study
NA · Instituto Portugues Oncologia de Lisboa Francisco Gentil · NCT06073561
This study is testing a new method for removing large colon polyps without injections to see if it works better and is safer than traditional techniques.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Portugues Oncologia de Lisboa Francisco Gentil (other) |
| Locations | 1 site (Lisboa) |
| Trial ID | NCT06073561 on ClinicalTrials.gov |
What this trial studies
This multi-centric study evaluates the learning curve of underwater endoscopic mucosal resection (U-EMR) performed by endoscopists experienced in conventional endoscopic mucosal resection (C-EMR). The study aims to assess the effectiveness of U-EMR in removing large non-pedunculated colon polyps without the need for submucosal injection, potentially reducing recurrence rates and procedure times. Participants will be monitored for the rate of complete resection and any adverse events associated with the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with at least one large non-pedunculated colon polyp measuring between 10 and 30 mm.
Not a fit: Patients with previous attempted resections, certain lesion locations, or specific conditions like inflammatory bowel disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes in the removal of large colon polyps with fewer complications.
How similar studies have performed: Previous studies have shown promising results with underwater endoscopic techniques, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lisboa
- Instituto Português de Oncologia de Lisboa Francisco Gentil — Lisboa, Portugal (RECRUITING)
Study contacts
- Study coordinator: Luís Correia Gomes, MD
- Email: luisfilipe.gomes@outlook.com
- Phone: +351914534888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colon Polyp, Adenoma Colon