Cold Snare Endoscopic Mucosal Resection Trial (LPS-II)

White River Junction Veterans Affairs Medical Center

Status: Active, not recruiting

Conditions: Colonic Polyp; Complication; Colonoscopy; Recurrence

Treatments: Procedure: Hot snare EMR; Procedure: Placebo injection; Procedure: Eleview injection; Procedure: Cold snare EMR

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03865537

119681

Details and patient eligibility

About

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.

Full 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.

Enrollment: 990 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient ≥18 who presents for a colonoscopy and who does not have criteria for exclusion
• Patients with a ≥20mm non-pedunculated colorectal polyp

Exclusion criteria

• Pedunculated polyps (as defined by Paris Classification type Ip)
• Suspected adenocarcinoma with deep submucosal invasion
• Patients with ulcerated depressed lesions (as defined by Paris Classification type III) or confirmed adenocarcinoma
• Patients with inflammatory bowel disease
• Patients who are receiving an emergency colonoscopy
• Poor general health (ASA class>3)
• Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
• Inadequate bowel preparation (Boston Bowel Prep Scale, total score ≤2)
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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990 participants in 4 patient groups

Cold snare & Eleview injection

Experimental group

Description:

Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview

Treatment:

Procedure: Cold snare EMR

Procedure: Eleview injection

Cold Snare & Placebo injection

Experimental group

Description:

Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo

Treatment:

Procedure: Cold snare EMR

Procedure: Placebo injection

Hot snare & Eleview injection

Active Comparator group

Description:

Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview

Treatment:

Procedure: Eleview injection

Procedure: Hot snare EMR

Hot snare & Placebo injection

Active Comparator group

Description:

Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo

Treatment:

Procedure: Placebo injection

Procedure: Hot snare EMR