Actively Recruiting
Reducing Neoplasia Recurrence After Endoscopic Resection of Large Colorectal Polyps
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-11-25
892
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new techniques to reduce the recurrence of large colorectal polyps, which can be precursors to colorectal cancer. The trial focuses on patients with large laterally spreading lesions (LSLs) of at least 20mm, which are treated via endoscopic mucosal resection (EMR). The study compares two ablation methods used after EMR to prevent polyp regrowth: hybrid argon plasma coagulation (h-APC) and snare tip soft coagulation (STSC). Participants will be randomly assigned to one of two groups after the initial EMR procedure. One group will receive additional h-APC to ablate both the margin and base of the polypectomy site, while the other group will receive STSC margin ablation only. The EMR involves lifting the polyp with a submucosal injection, followed by snare electrocautery resection. If multiple polyps are present, the study polyp will be marked for follow-up. Follow-up includes colonoscopies and biopsies at 6 months and approximately 18 months to check for recurrence. During the study, participants undergo colonoscopy preparation before the procedure and receive the assigned ablation treatment during EMR. Telephone follow-up occurs 14 days post-procedure to monitor for adverse events. Subsequent colonoscopies assess polyp recurrence, with additional treatment if recurrence is detected. Researchers will measure recurrence rates, adverse events, technical success of ablation, and occurrence of high-grade dysplasia or colorectal cancer over a 4-year period.
CONDITIONS
Brief Title
Reducing Neoplasia Recurrence After Endoscopic Resection of Large Colorectal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult 18 years or older
- Undergoing endoscopic mucosal resection (EMR) for a large (≥20mm) colorectal laterally spreading lesion (LSL)
- Providing written and informed consent for study participation
You will not qualify if you...
- Inflammatory bowel disease
- Non-elective colonoscopy
- Poor general health (American Society of Anesthesiologists classification >III)
- Coagulopathy or thrombocytopenia (INR ≥1.5 or platelets <50 x 10^9/L)
- Pedunculated polyps (Paris class Ip, Isp)
- Overt signs of deep submucosal invasive cancer (JNET 3)
- Biopsy-proven invasive carcinoma in a potential study polyp
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Day of EMR procedure
Participants undergo endoscopic mucosal resection (EMR) for removal of large colorectal polyps, followed by randomized margin ablation with either hybrid argon plasma coagulation (h-APC) or snare tip soft coagulation (STSC).
1 procedure visit (in-person)
Duration - 14 days after EMR
Participants receive a telephone call 14 days after EMR to assess for any adverse events following the procedure.
1 telephone follow-up
Duration - 6 months and approximately 18 months after EMR
Participants undergo surveillance colonoscopies to assess for polyp recurrence at the EMR site, including biopsies for pathology confirmation.
2 colonoscopy visits (in-person)
Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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