Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

study id #: NCT02470416

condition: Polyps

status: Recruiting

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.

intervention: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD

start date: October 2015

estimated completion: July 2016

last updated: December 15, 2015

phase of development: Not Available

size / enrollment: 200

study design:
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

study 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.

primary outcomes:

• Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas [Time Frame:24 months] [Designated as safety issue: No]

secondary outcomes:

• Number of participants with presence and prevalence of colonic polyps [Time Frame:24 months] [Designated as safety issue:No]

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: Not Available

sponsor: Western Sydney Local Health District

contacts:
Rebecca Sonson
98459779
Rebecca.Sonson@health.nsw.gov.au

investigators: Michael Bourke, MBBS FRACP

locations: Australia