Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
The Cleveland Clinic
Summary
The goal of this randomized clinical trial is to learn if a combination of hot and cold EMR technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps. Participants will undergo EMR and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult patient (age 18 years or older) * Polyp size of at least 20 mm * \- Morphology: Flat or superficially raised polyp morphology (i.e., Paris classification 1s, 0-IIa or 0-IIb, or a combination of the above) Exclusion Criteria: * Polyps with previous failed resection attempts or polyp recurrence * Suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (Kudo V or NICE 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma) * Polyps with nodules too large (\>1-1.5cm) for the use of a cold snare * Inflammatory bow…
Interventions
- ProcedureCold EMR
Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared.
- ProcedureHybrid EMR
Cold EMR with hot avulsion of any visible residual neoplasia within the resection bed, in addition to precise APC of the fibrotic bands that may harbor invisible neoplasia within the resection bed.
Locations (2)
- Cleveland Clinic WestonWeston, Florida
- Cleveland ClinicCleveland, Ohio