Clinical Trials Directory

Trials / Completed

CompletedNCT02470416

Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

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 Polyposis (FAP) or Peutz Jeghers Syndrom (PJS).

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
177 (actual)
Sponsor
Western Sydney Local Health District · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
DEVICESmall bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTDCases and controls will have a standard VCE procedure at our institution.

Timeline

Start date
2015-10-01
Primary completion
2018-01-01
Completion
2020-08-01
First posted
2015-06-12
Last updated
2023-06-29

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT02470416. Inclusion in this directory is not an endorsement.