Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths.
Ann G Zauber, Sidney J Winawer, Michael J O'Brien...
https://pubmed.ncbi.nlm.nih.gov/22356322Actively Recruiting
Age: 18Years +
All Genders
ID06476145
Prospective Randomized Controlled Trial Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation
Led by AdventHealth · Updated on 2026-01-05
342
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
Sponsors
A
AdventHealth
Lead Sponsor
N
Northwestern University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two methods to reduce the return of adenomas, which are non-pedunculated colon polyps, after they are removed using endoscopic mucosal resection (EMR). This study evaluates whether marking the margin of the polyp before removal or using thermal margin ablation after removal results in similar rates of adenoma recurrence. The trial focuses on polyps that are 20 mm or larger and aims to understand which method may better prevent polyp recurrence. The study involves two groups: one group will have mucosal markings placed just outside the polyp edge using superficial cautery marks with an endoscopic snare tip. The other group will receive thermal margin ablation, applying soft coagulation around the entire margin of the mucosal defect after polyp removal to create a rim of ablated tissue. Both procedures are done during colonoscopy following standard EMR techniques. Participants will undergo the procedure and then be monitored for adenoma recurrence between 3 and 12 months after treatment. Researchers will also track procedure time and monitor for any severe adverse events such as bleeding, perforation, or postpolypectomy syndrome up to 30 days post-procedure. The study period includes the initial colonoscopy and follow-up visits to evaluate outcomes and safety over time.
CONDITIONS
Brief Title
Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to provide informed consent
- Scheduled for colonoscopy to evaluate and remove colon polyps
- Presence of non-pedunculated polyps 20 mm or larger in size
You will not qualify if you...
- Presence of pedunculated polyps
- Diagnosis of inflammatory bowel disease
- Inability to provide informed consent
- Lesions smaller than 20 mm in largest dimension
- Lesions involving the lips of the ileocecal valve, appendiceal orifice, or fully circumferential
- Any standard contraindication to anesthesia or colonoscopy, including pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Day of procedure
Participants undergo colonoscopy to evaluate and remove colon polyps using one of two endoscopic mucosal resection methods.
1 visit (in-person)
Surveillance
Duration - 3 to 12 months (+/- 6 months)
Participants are monitored for adenoma recurrence after the endoscopic mucosal resection procedure.
1 to 2 visits depending on follow-up schedule
Trial Site Locations
Total: 1 location
1
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
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Research Team
D
Diana Paredes, RN
P
Petronio Martins, MHA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Mahesh Jayanna, Nicholas G Burgess, Rajvinder Singh...
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Golo Ahlenstiel, Luke F Hourigan, Gregor Brown...
https://pubmed.ncbi.nlm.nih.gov/24916925Treatment with argon plasma coagulation reduces recurrence after piecemeal resection of large sessile colonic polyps: a randomized trial and recommendations.
Jim C Brooker, Brian P Saunders, Syed G Shah...
https://pubmed.ncbi.nlm.nih.gov/11868011Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia.
Alan Moss, Michael J Bourke, Stephen J Williams...
https://pubmed.ncbi.nlm.nih.gov/21392504Endoscopic mucosal resection of 161 cases of large sessile or flat colorectal polyps.
Naila Arebi, David Swain, Noriko Suzuki...
https://pubmed.ncbi.nlm.nih.gov/17558911Prophylactic Snare Tip Soft Coagulation and Its Impact on Adenoma Recurrence After Colonic Endoscopic Mucosal Resection.
Pujan Kandel, Monia E Werlang, Issac R Ahn...
https://pubmed.ncbi.nlm.nih.gov/31098871Thermal Ablation of Mucosal Defect Margins Reduces Adenoma Recurrence After Colonic Endoscopic Mucosal Resection.
Amir Klein, David J Tate, Vanoo Jayasekeran...
https://pubmed.ncbi.nlm.nih.gov/30296436Outcomes of Thermal Ablation of the Mucosal Defect Margin After Endoscopic Mucosal Resection: A Prospective, International, Multicenter Trial of 1000 Large Nonpedunculated Colorectal Polyps.
Mayenaaz Sidhu, Neal Shahidi, Sunil Gupta...
https://pubmed.ncbi.nlm.nih.gov/33798525A retrospective comparative study of argon plasma versus polypectome snare tip coagulation: effect on recurrence rate after resection of large laterally spreading type lesions.
Panagiotis Katsinelos, Georgia Lazaraki, Grigoris Chatzimavroudis...
https://pubmed.ncbi.nlm.nih.gov/30837791