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Completed

NCT Number: NCT02470416

Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

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.

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Key information

Conditions

Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas

    Time frame: 24 months

Secondary outcomes

  1. Number of participants with presence and prevalence of colonic polyps

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Collaborators

  • Westmead Hospital

Registry information

Official study title

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).

Acronym: SPIDA

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jun 12, 2015
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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