Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

study id #: NCT02470416

condition: Polyps

status: active, not 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 2018

last updated: July 4, 2019

phase of development: Not Available

size / enrollment: 177

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]

secondary outcomes:

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

inclusion criteria:

exclusion criteria:
• None

sponsor: Western Sydney Local Health District

trial center locations: Australia