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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
| Steris | UNKNOWN |
| Cosmo Pharmaceuticals | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold snare & Eleview injection | Experimental | Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview |
|
| Cold Snare & Placebo injection | Experimental | Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo |
|
| Hot snare & Eleview injection | Active Comparator | Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview |
|
| Hot snare & Placebo injection | Active Comparator | Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold snare EMR | Procedure | Participants will have their large polyp removed without electrocautery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe Adverse Events | Aggregate of all severe adverse events that occur at the time of the colonoscopy with resection of the large polyp or following the procedure | up to 30 days following the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Subcategories of severe adverse events | Bleeding, post-polypectomy syndrome, perforation, abdominal pain | during the procedure and up to 30 days following the procedure |
| Performance submucosal injectate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heiko Pohl, MD | White River Junction VAMC, Geisel School of Medicine at Dartmouth | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| White River Junction VAMC | White River Junction | Vermont | 05009 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40393701 | Derived | Pohl H, Rex DK, Barber J, Moyer MT, Elmunzer BJ, Rastogi A, Gordon SR, Zolotarevsky E, Levenick JM, Aslanian HR, Elatrache M, von Renteln D, Wallace MB, Brahmbhatt B, Keswani RN, Kumta NA, Pleskow DK, Smith ZL, Abu Ghanimeh MK, Simmer S, Sanaei O, Mackenzie TA, Piraka C. Cold snare endoscopic resection for large colon polyps: a randomised trial. Gut. 2025 Oct 8;74(11):1804-1813. doi: 10.1136/gutjnl-2025-335075. | |
| 38191267 |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000706807 | SIC-8000 |
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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).
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Randomization 1 (Cold vs. hot snare group): Masking only of participants Randomization 2 (Eleview vs Placebo): Masking of all checked above
| Hot snare EMR | Procedure | Participants will have their large polyp removed with electrocautery |
|
| Eleview injection | Procedure | Participants will have their polyp submucosally injected with Eleview |
|
| Placebo injection | Procedure | Participants will have their polyp submucosally injected with placebo |
|
Injection performance
| immediately following polyp resection during the colonoscopy |
| Volume of submucosal injectate | volume of injection | immediately following polyp resection during the colonoscopy |
| Efficacy of submucosal injectate | Sidney index | immediately following polyp resection during the colonoscopy |
| Completeness of polyp resection | Complete polyp removal is defined as removal of all visible polyp tissue at the end of the EMR, as assessed by the endoscopist. | immediately following polyp resection during the colonoscopy |
| Intraprocedural bleeding | bleeding that requires endoscopic intervention to stop the bleeding | at the time of polyp resection |
| Polyp recurrence | Presence of biopsy proven neoplastic polyp tissue at the EMR resection site at surveillance colonoscopy following complete polyp resection | at surveillance colonoscopies up to 5 years following the initial polyp resection |
| Crossover from cold to hot snare | 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 | at the time of polyp resection |
| Derived |
| Djinbachian R, von Renteln D. Thermal ablation of the resection base after endoscopic mucosal resection: a useful tool when perfect technique is not achievable. Gut. 2024 Sep 9;73(10):e19. doi: 10.1136/gutjnl-2023-331676. No abstract available. |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |