Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas (SPIDA)

Western Sydney Local Health District

Status: Completed

Conditions: Polyps

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02470416

HREC/14/WMEAD/226(4028)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 2 patient groups

Case

Active Comparator group

Description:

Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital

Treatment:

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

Control

Active Comparator group

Description:

Age matched controls having VCE for OGIB/IDA at Westmead hospital.

Treatment:

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