Clinical trial NCT03865537: Cold Snare Endoscopic Mucosal Resection Trial
Official title: Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colonic Polyp
Colonoscopy
Complication
Recurrence
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Dartmouth College
name: Steris
name: Cosmo Pharmaceuticals
First posted: 2019-03-07
Enrollment: 990
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Severe Adverse Events
timeFrame: up to 30 days following the procedure
Secondary outcomes:
measure: Subcategories of severe adverse events
timeFrame: during the procedure and up to 30 days following the procedure
measure: Performance submucosal injectate
timeFrame: immediately following polyp resection during the colonoscopy
measure: Volume of submucosal injectate
timeFrame: immediately following polyp resection during the colonoscopy
measure: Efficacy of submucosal injectate
timeFrame: immediately following polyp resection during the colonoscopy
measure: Completeness of polyp resection
timeFrame: immediately following polyp resection during the colonoscopy
measure: Intraprocedural bleeding
timeFrame: at the time of polyp resection
measure: Polyp recurrence
timeFrame: at surveillance colonoscopies up to 5 years following the initial polyp resection
measure: Crossover from cold to hot snare
timeFrame: at the time of polyp resection
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: White River Junction VAMC
state: Vermont
Study officials:
affiliation: White River Junction VAMC, Geisel School of Medicine at Dartmouth
name: Heiko Pohl, MD
role: STUDY_CHAIR
References: