Colonic Polyp, Colonoscopy, Complication, Recurrence
Conditions
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.
Interventions
PROCEDURECold snare EMR
Participants will have their large polyp removed without electrocautery
PROCEDUREHot snare EMR
Participants will have their large polyp removed with electrocautery
PROCEDUREEleview injection
Participants will have their polyp submucosally injected with Eleview
PROCEDUREPlacebo injection
Participants will have their polyp submucosally injected with placebo
Sponsors
Dartmouth College
Steris
Cosmo Pharmaceuticals
White River Junction Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomization 1 (Cold vs. hot snare group): Masking only of participants Randomization 2 (Eleview vs Placebo): Masking of all checked above
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Performance submucosal injectate | immediately following polyp resection during the colonoscopy | Injection performance |
| Volume of submucosal injectate | immediately following polyp resection during the colonoscopy | volume of injection |
| Efficacy of submucosal injectate | immediately following polyp resection during the colonoscopy | Sidney index |
| Subcategories of severe adverse events | during the procedure and up to 30 days following the procedure | Bleeding, post-polypectomy syndrome, perforation, abdominal pain |
| Intraprocedural bleeding | at the time of polyp resection | bleeding that requires endoscopic intervention to stop the bleeding |
| 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 |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed