NCT03865537

Cold Snare Endoscopic Mucosal Resection Trial

Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 990 (actual)
• Sponsor: White River Junction Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Colonic Polyp
• Colonoscopy
• Complication
• Recurrence

Interventions

Type	Name	Description
PROCEDURE	Cold snare EMR	Participants will have their large polyp removed without electrocautery
PROCEDURE	Hot snare EMR	Participants will have their large polyp removed with electrocautery
PROCEDURE	Eleview injection	Participants will have their polyp submucosally injected with Eleview
PROCEDURE	Placebo injection	Participants will have their polyp submucosally injected with placebo

Timeline

• Start date: 2019-10-01
• Primary completion: 2024-05-31
• Completion: 2027-01-01
• First posted: 2019-03-07
• Last updated: 2024-06-21

Locations

1 site across 1 country: United States