Clinical Trial: Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Case Control Study on the Prevalence of Small Bowel and Colonic Polyps in Patients With Duodenal Adenomas/Ampullomas Who do Not Have Familial Adenomatous Pol

Brief Summary: Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small bowel polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas by performing small bowel capsule endoscopy and comparing the results to those acquired from a control cohort undergoing VCE for accepted indication at our centre.

Detailed Summary:

Investigation for suspected SB tumors is an acceptable indication for VCE. SB polyps occur frequently in patients with FAP/PJS and in patients with FAP, they are significantly more common in patients with Duodenal/Ampullary polyps. Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps.

The primary hypothesis is that patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas have a higher prevalence of small bowel polyps compared with patients undergoing VCE for various indications who have not had a duodenal polyp diagnosed or removed.

Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital will receive VCE examination. Control population will consist of age matched controls having VCE for OGIB/IDA at Westmead hospital. Patients will be required to have had a documented colonoscopy within the previous three years. If colonoscopy was not performed within this time frame, the patient will have a colonoscopy as part of the study protocol.

Sponsor: Western Sydney Local Health District

Current Primary Outcome: Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of participants with presence and prevalence of colonic polyps [ Time Frame: 24 months ]

Original Secondary Outcome: Same as current

Information By: Western Sydney Local Health District

Dates:
Date Received: June 2, 2015
Date Started: October 2015
Date Completion: July 2016
Last Updated: December 15, 2015
Last Verified: December 2015