Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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 bowel disease
Trial design
Treatments tested in this trial
- Cold EMR
- Hybrid EMR
Treatment groups
194 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov