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Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas (SPIDA)

Primary Purpose

Polyps

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD
Sponsored by
Western Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Polyps focused on measuring duodenal, ampulla

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Westmead Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Case

Control

Arm Description

Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital

Age matched controls having VCE for OGIB/IDA at Westmead hospital.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants with presence and prevalence of colonic polyps

Full Information

First Posted
June 2, 2015
Last Updated
June 28, 2023
Sponsor
Western Sydney Local Health District
Collaborators
Westmead hospital Westmead NSW 2145 Australia
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1. Study Identification

Unique Protocol Identification Number
NCT02470416
Brief Title
Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas
Acronym
SPIDA
Official 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).
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Sydney Local Health District
Collaborators
Westmead hospital Westmead NSW 2145 Australia

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyps
Keywords
duodenal, ampulla

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case
Arm Type
Active Comparator
Arm Description
Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Age matched controls having VCE for OGIB/IDA at Westmead hospital.
Intervention Type
Device
Intervention Name(s)
Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD
Intervention Description
Cases and controls will have a standard VCE procedure at our institution.
Primary Outcome Measure Information:
Title
Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of participants with presence and prevalence of colonic polyps
Time Frame
24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bourke, MBBS, FRACP
Organizational Affiliation
WSLHD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
32717365
Citation
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.
Results Reference
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Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

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