An interventional study of Cold snare EMR and Hot snare EMR in Colonic Polyp, Colonoscopy and Complication, sponsored by White River Junction Veterans Affairs Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by White River Junction Veterans Affairs Medical Center · Not applicable, Interventional, and Treatment
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.
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's enrollment of 990 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →White River Junction Veterans Affairs Medical Center is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Eleview
Procedure: Cold snare EMR · Procedure: Eleview injection
Polyp resection without electrocautery (cold snare EMR), and initial submucosal injection with Placebo
Procedure: Cold snare EMR · Procedure: Placebo injection
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Eleview
Procedure: Hot snare EMR · Procedure: Eleview injection
Polyp resection with electrocautery (hot snare EMR), and initial submucosal injection with Placebo
Procedure: Hot snare EMR · Procedure: Placebo injection
Participants will have their large polyp removed without electrocautery
Participants will have their large polyp removed with electrocautery
Participants will have their polyp submucosally injected with Eleview
Participants will have their polyp submucosally injected with placebo
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
Time frame: up to 30 days following the procedure
Subcategories of severe adverse events
Bleeding, post-polypectomy syndrome, perforation, abdominal pain
Time frame: during the procedure and up to 30 days following the procedure
Performance submucosal injectate
Injection performance
Time frame: immediately following polyp resection during the colonoscopy
Volume of submucosal injectate
volume of injection
Time frame: immediately following polyp resection during the colonoscopy
Efficacy of submucosal injectate
Sidney index
Time frame: 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.
Time frame: immediately following polyp resection during the colonoscopy
Intraprocedural bleeding
bleeding that requires endoscopic intervention to stop the bleeding
Time frame: 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
Time frame: 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
Time frame: at the time of polyp resection
This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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White River Junction Veterans Affairs Medical Center