Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas
NCT ID: NCT02470416
Last Updated: 2023-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
177 participants
INTERVENTIONAL
2015-10-31
2020-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Case
Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital
Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD
Cases and controls will have a standard VCE procedure at our institution.
Control
Age matched controls having VCE for OGIB/IDA at Westmead hospital.
Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD
Cases and controls will have a standard VCE procedure at our institution.
Interventions
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Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD
Cases and controls will have a standard VCE procedure at our institution.
Eligibility Criteria
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Inclusion Criteria
* Controls - Patients undergoing VCE procedure for the evaluation of obscure gastrointestinal bleeding (OGIB) or Iron deficiency anemia (IDA).
Exclusion Criteria
ALL
No
Sponsors
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Westmead hospital Westmead NSW 2145 Australia
UNKNOWN
Western Sydney Local Health District
OTHER
Responsible Party
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Professor Michael Bourke
Professor of medicine
Principal Investigators
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Michael Bourke, MBBS, FRACP
Role: PRINCIPAL_INVESTIGATOR
WSLHD
Locations
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Westmead Hospital
Westmead, New South Wales, Australia
Countries
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References
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Awadie H, Klein A, Tate D, Jideh B, Bar-Yishai I, Goodrick K, Ahlenstiel G, Bourke MJ. The prevalence of small-bowel polyps on video capsule endoscopy in patients with sporadic duodenal or ampullary adenomas. Gastrointest Endosc. 2021 Mar;93(3):630-636. doi: 10.1016/j.gie.2020.07.029. Epub 2020 Jul 24.
Other Identifiers
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HREC/14/WMEAD/226(4028)
Identifier Type: -
Identifier Source: org_study_id
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