Cold Snare Endoscopic Mucosal Resection Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colonic Polyp
- Colonoscopy
- Complication
- Recurrence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: 2 x 2 randomized trial. First randomization: Among half of patients with a large polyp will be removed by electrocautery ("hot") snare resection, and the other half will have their polyp removed by snare resection without electrocautery ("cold"). Second randomization: Among half of patients the large polyp will by lifted (submucosal injection before resection) with Eleview; among the other by Placebo (Normal Saline with Methylene Blue).Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Randomization 1 (Cold vs. hot snare group): Masking only of participants Randomization 2 (Eleview vs Placebo): Masking of all checked abovePrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Electrocautery, or hot snare resection has long been considered the standard approach to polyp resection. A major limitation is a 5 to 10% risk of major adverse events. Recent studies suggest that snare resection without electrocautery - so-called cold snare EMR - may be safer than hot snare EMR. Th...
Electrocautery, or hot snare resection has long been considered the standard approach to polyp resection. A major limitation is a 5 to 10% risk of major adverse events. Recent studies suggest that snare resection without electrocautery - so-called cold snare EMR - may be safer than hot snare EMR. The concern with cold snare resection is a potentially lower efficacy, because cold snare resection requires the removal of a large polyp in smaller and greater number of pieces than with hot snare resection. This may lengthen procedure time and increase the risk of incomplete resection. Furthermore, there is uncertainty about the optimal injection solution for lifting of the polyp prior to resection. Normal saline with methylene blue as the contrast agent is frequently used, but is limited by fast dissipation of the polyp lift. Eleview is a newly approved viscous solution (that contains methylene blue), which provides a longer polyp lift than normal saline. It is unclear how these two solutions compare with respect to resection efficacy and safety.
Tracking Information
- NCT #
- NCT03865537
- Collaborators
- Dartmouth College
- US Endoscopy
- Aries Pharmaceuticals, Inc.
- Investigators
- Study Chair: Heiko Pohl, MD White River Junction VAMC, Geisel School of Medicine at Dartmouth
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