Recruiting NCT06937671
Randomized Trial of Cold EMR Compared to Hybrid Cold EMR.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cold EMR, Hybrid EMR.
- Who it may be relevant to
- Registry conditions: Polyp of Colon, Endoscopic Mucosal Resection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Cold EMR
Cold EMR with cold forceps (regular or jumbo forceps) removal of any visible neoplasia that cannot be ensnared. - Procedure Hybrid 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.
Primary outcome measures
- Recurrence of polyps [Time frame: 3-6 months after the procedure]
Secondary outcome measures (4)
- Adverse events [Time frame: 3-6 months after the procedure]
- Polyp recurrence rates [Time frame: 3-6 months after EMR procedure]
- Cost benefit analysis [Time frame: 3-6 months after the procedure]
- Subgroup polyp recurrence rate [Time frame: 3-6 months after the procedure]
Eligibility criteria
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 bowel disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Cleveland Clinic Weston — Weston
- Cleveland Clinic — Cleveland
Identifiers
NCT: NCT06937671 · 25-126