Cold Snare Endoscopic Mucosal Resection Trial
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- STATUS
- Recruiting
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- End date
- Apr 1, 2027
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- participants needed
- 870
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- sponsor
- White River Junction Veterans Affairs Medical Center
Summary
This study compares different approaches to endoscopic mucosal resection (EMR) of large non-pedunculated colorectal polyps (20mm) in a 2 x 2 randomized design. The first randomization will assign half of patients to polyp resection with electrocautery ("hot" snare EMR) and half of patient to polyp resection without electrocautery ("cold" snare EMR). The second randomization will assign half of patients to polyp removal using Eleview as the submucosal injection agent, and the other half using placebo (normal saline with methylene blue) as the submucosal injection agent.
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. 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.
Details
| Condition | complications medical, relapse/recurrence, Medical Complication, colonoscopy, Relapse, Complication, COLONIC POLYP, Colon Polyps |
|---|---|
| Treatment | Placebo Injection, Cold snare EMR, Hot snare EMR, Eleview injection |
| Clinical Study Identifier | NCT03865537 |
| Sponsor | White River Junction Veterans Affairs Medical Center |
| Last Modified on | 10 June 2021 |
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