Actively Recruiting
Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
Led by Western Sydney Local Health District · Updated on 2025-03-27
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting prospective observational data on patients diagnosed with Familial Adenomatous Polyposis (FAP) who are undergoing cold snare polypectomy to remove duodenal adenomas. FAP is a genetic condition causing numerous colorectal polyps and has a high risk of colorectal cancer if untreated. Upper gastrointestinal adenomas are common in FAP, and managing duodenal adenomas remains challenging despite surgical advances. The study focuses on evaluating the cold snare polypectomy technique, which avoids thermal therapy by removing adenomas using a cold snare, potentially reducing bleeding risks seen with other methods like endoscopic mucosal resection (EMR). This method has been previously used safely for colorectal polyps and in small case series for duodenal adenomas but has not been studied extensively in larger groups. Patients with FAP and duodenal adenomas undergoing this procedure are observed over time. Participants are monitored for serious and non-serious adverse events over three years, including procedure duration, perforations, post-procedure pain, hospital readmissions, and changes in Spigelman stage—a system that classifies duodenal adenoma severity. The study tracks safety outcomes and the procedure's effects during routine surveillance for FAP, with no intervention beyond observation of standard care.
CONDITIONS
Brief Title
Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Familial Adenomatous Polyposis confirmed by genetic testing and able to give informed consent
- Currently undergoing endoscopic surveillance for FAP
You will not qualify if you...
- Known strictures or stenosis
- Pregnant
- Did not consent to the study
- Have a bleeding disorder (bleeding diathesis)
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.
1 visit (in-person)
Duration - Up to 3 years
Participants undergo endoscopic surveillance to assess duodenal adenomas associated with Familial Adenomatous Polyposis (FAP).
Regular endoscopic assessments as part of surveillance
Duration - Up to 3 years
Participants are monitored for safety outcomes such as adverse events, procedure duration, perforation, pain, hospital readmission, and changes in Spigelman stage over time.
Follow-up visits following endoscopic procedures as needed
Trial Site Locations
Total: 1 location
1
Westmead Endoscopy Unit
Westmead, New South Wales, Australia, 2145
Actively Recruiting
Research Team
M
Michael J Bourke, MBBS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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