Cold Snare Endoscopic Mucosal Resection Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

990 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2027-01-31

Brief Summary

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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.

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Detailed Description

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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

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Colonic Polyp Colonoscopy Complication Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Randomization 1 (Cold vs. hot snare group): Masking only of participants Randomization 2 (Eleview vs Placebo): Masking of all checked above

Study Groups

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Cold snare & Eleview injection

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

Group Type EXPERIMENTAL

Cold snare EMR

Intervention Type PROCEDURE

Participants will have their large polyp removed without electrocautery

Eleview injection

Intervention Type PROCEDURE

Participants will have their polyp submucosally injected with Eleview

Cold Snare & Placebo injection

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

Group Type EXPERIMENTAL

Cold snare EMR

Intervention Type PROCEDURE

Participants will have their large polyp removed without electrocautery

Placebo injection

Intervention Type PROCEDURE

Participants will have their polyp submucosally injected with placebo

Hot snare & Eleview injection

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

Group Type ACTIVE_COMPARATOR

Hot snare EMR

Intervention Type PROCEDURE

Participants will have their large polyp removed with electrocautery

Eleview injection

Intervention Type PROCEDURE

Participants will have their polyp submucosally injected with Eleview

Hot snare & Placebo injection

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

Group Type ACTIVE_COMPARATOR

Hot snare EMR

Intervention Type PROCEDURE

Participants will have their large polyp removed with electrocautery

Placebo injection

Intervention Type PROCEDURE

Participants will have their polyp submucosally injected with placebo

Interventions

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Cold snare EMR

Participants will have their large polyp removed without electrocautery

Intervention Type PROCEDURE

Hot snare EMR

Participants will have their large polyp removed with electrocautery

Intervention Type PROCEDURE

Eleview injection

Participants will have their polyp submucosally injected with Eleview

Intervention Type PROCEDURE

Placebo injection

Participants will have their polyp submucosally injected with placebo

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No