Cold Snare Endoscopic Mucosal Resection Trial
- Conditions
- Colonic PolypComplicationRecurrenceColonoscopy
- Interventions
- Procedure: Cold snare EMRProcedure: Hot snare EMRProcedure: Eleview injectionProcedure: Placebo injection
- Registration Number
- NCT03865537
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 990
- Any patient ≥18 who presents for a colonoscopy and who does not have criteria for exclusion
- Patients with a ≥20mm non-pedunculated colorectal polyp
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Cold snare & Eleview injection Cold snare EMR Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview Cold Snare & Placebo injection Cold snare EMR Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo Hot snare & Eleview injection Eleview injection Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview Cold Snare & Placebo injection Placebo injection Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo Hot snare & Placebo injection Hot snare EMR Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo Hot snare & Placebo injection Placebo injection Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo Hot snare & Eleview injection Hot snare EMR Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview Cold snare & Eleview injection Eleview injection Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview
- Primary Outcome Measures
Name Time Method Severe Adverse Events 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 Outcome Measures
Name Time Method Completeness of polyp resection 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 at the time of polyp resection bleeding that requires endoscopic intervention to stop the bleeding
Subcategories of severe adverse events during the procedure and up to 30 days following the procedure Bleeding, post-polypectomy syndrome, perforation, abdominal pain
Performance submucosal injectate immediately following polyp resection during the colonoscopy Injection performance
Polyp recurrence 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
Efficacy of submucosal injectate immediately following polyp resection during the colonoscopy Sidney index
Volume of submucosal injectate immediately following polyp resection during the colonoscopy volume of injection
Crossover from cold to hot snare 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
Trial Locations
- Locations (1)
White River Junction VAMC
🇺🇸White River Junction, Vermont, United States