Cold Snare Endoscopic Mucosal Resection Trial

Overview

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 Title of Study: “Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Cold snare & Eleview injection
    • Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview
  • Experimental: Cold Snare & Placebo injection
    • Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo
  • Active Comparator: Hot snare & Eleview injection
    • Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview
  • Active Comparator: Hot snare & Placebo injection
    • Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Severe Adverse Events
    • Time Frame: up to 30 days following the procedure
    • Aggregate of all severe adverse events that occur at the time of the colonoscopy with resection of the large polyp or following the procedure

Secondary Measures

  • Subcategories of severe adverse events
    • Time Frame: during the procedure and up to 30 days following the procedure
    • Bleeding, post-polypectomy syndrome, perforation, abdominal pain
  • Performance submucosal injectate
    • Time Frame: immediately following polyp resection during the colonoscopy
    • Injection performance
  • Volume of submucosal injectate
    • Time Frame: immediately following polyp resection during the colonoscopy
    • volume of injection
  • Efficacy of submucosal injectate
    • Time Frame: immediately following polyp resection during the colonoscopy
    • Sidney index
  • Completeness of polyp resection
    • Time Frame: immediately following polyp resection during the colonoscopy
    • Complete polyp removal is defined as removal of all visible polyp tissue at the end of the EMR, as assessed by the endoscopist.
  • Intraprocedural bleeding
    • Time Frame: at the time of polyp resection
    • bleeding that requires endoscopic intervention to stop the bleeding
  • Polyp recurrence
    • Time Frame: at surveillance colonoscopies up to 5 years following the initial polyp resection
    • Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance colonoscopy following complete polyp resection
  • Crossover from cold to hot snare
    • Time Frame: at the time of polyp resection
    • Proportion of polyps in the cold snare group that could not be removed by cold snare and were removed by hot snare, categorized by size and morphology subtypes of polyps

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • White River Junction Veterans Affairs Medical Center
  • Collaborator
    • Dartmouth College
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Heiko Pohl, Associate Professor or Medicine – White River Junction Veterans Affairs Medical Center
  • Overall Official(s)
    • Heiko Pohl, MD, Study Chair, White River Junction VAMC, Geisel School of Medicine at Dartmouth
  • Overall Contact(s)
    • Heiko Pohl, MD, 8022959363, heiko.pohl@dartmouth.edu

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