Colonoscopy Clinical Trial
— LPS-IIOfficial title:
Cold Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial
Verified date | June 2024 |
Source | White River Junction Veterans Affairs Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 990 |
Est. completion date | January 2027 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | White River Junction VAMC | White River Junction | Vermont |
Lead Sponsor | Collaborator |
---|---|
White River Junction Veterans Affairs Medical Center | Cosmo Pharmaceuticals, Dartmouth College, Steris |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Subcategories of severe adverse events | Bleeding, post-polypectomy syndrome, perforation, abdominal pain | during the procedure and up to 30 days following the procedure | |
Secondary | Performance submucosal injectate | Injection performance | immediately following polyp resection during the colonoscopy | |
Secondary | Volume of submucosal injectate | volume of injection | immediately following polyp resection during the colonoscopy | |
Secondary | Efficacy of submucosal injectate | Sidney index | immediately following polyp resection during the colonoscopy | |
Secondary | 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 | |
Secondary | Intraprocedural bleeding | bleeding that requires endoscopic intervention to stop the bleeding | at the time of polyp resection | |
Secondary | 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 | |
Secondary | 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 |
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