Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas
SPIDA
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).
1 other identifier
interventional
177
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 12, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedJune 29, 2023
June 1, 2023
2.3 years
June 2, 2015
June 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas
24 months
Secondary Outcomes (1)
Number of participants with presence and prevalence of colonic polyps
24 months
Study Arms (2)
Case
ACTIVE COMPARATORPatients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital
Control
ACTIVE COMPARATORAge matched controls having VCE for OGIB/IDA at Westmead hospital.
Interventions
Cases and controls will have a standard VCE procedure at our institution.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Related Publications (1)
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.
PMID: 32717365DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bourke, MBBS, FRACP
WSLHD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of medicine
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 12, 2015
Study Start
October 1, 2015
Primary Completion
January 1, 2018
Study Completion
August 1, 2020
Last Updated
June 29, 2023
Record last verified: 2023-06