Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

Study Overview
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Brief Summary
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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
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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.

Official Title
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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).

Conditions
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Polyps

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


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Case<br>Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital | Device: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD<br>* Cases and controls will have a standard VCE procedure at our institution.<br>|
| Active Comparator: Control<br>Age matched controls having VCE for OGIB/IDA at Westmead hospital. | Device: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD<br>* Cases and controls will have a standard VCE procedure at our institution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with presence and prevalence of colonic polyps |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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duodenal, ampulla