Actively Recruiting

Age: 18Years - 99Years
All Genders
ID03471403

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

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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 - 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

Long-term Monitoring

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

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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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