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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02470416

Acronym

SPIDA

Enrollment

177

Registered

2015-06-12

Start date

2015-10-31

Completion date

2020-08-31

Last updated

2023-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyps

Keywords

duodenal, ampulla

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.

Interventions

DEVICESmall bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD

Cases and controls will have a standard VCE procedure at our institution.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Number of participants with presence and prevalence of colonic polyps	24 months

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026