Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

Not Applicable

Completed

• Conditions: Polyps
• Interventions: Device: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD

• Registration Number: NCT02470416
• Lead Sponsor: Western Sydney Local Health District

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 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.

Study Timeline

• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-12
• Study Start: 2015-10
• Primary Completion: 2018-01
• Study Completion: 2020-08
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• Cases - Patients who were diagnosed with or underwent resection of a duodenal adenoma/ampulloma at Westmead hospital between the years 2005-2014.
• Controls - Patients undergoing VCE procedure for the evaluation of obscure gastrointestinal bleeding (OGIB) or Iron deficiency anemia (IDA).

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case	Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD	Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital
Control	Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD	Age matched controls having VCE for OGIB/IDA at Westmead hospital.

Primary Outcome Measures

Name	Time	Method
Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas	24 months

Secondary Outcome Measures

Name	Time	Method
Number of participants with presence and prevalence of colonic polyps	24 months

Trial Locations

Locations (1)

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia