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

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ClinicalTrials.gov Identifier: NCT02470416
Recruitment Status : Recruiting
First Posted : June 12, 2015
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Westmead hospital Westmead NSW 2145 Australia
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

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.

Condition or disease Intervention/treatment Phase
Polyps Device: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : October 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
Active Comparator: Case
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
Cases and controls will have a standard VCE procedure at our institution.

Active Comparator: Control
Age matched controls having VCE for OGIB/IDA at Westmead hospital.
Device: Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD
Cases and controls will have a standard VCE procedure at our institution.




Primary Outcome Measures :
  1. Number of participants with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Number of participants with presence and prevalence of colonic polyps [ Time Frame: 24 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470416


Locations
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Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Rebecca Sonson    98459779    Rebecca.Sonson@health.nsw.gov.au   
Principal Investigator: Michael Bourke, MBBS FRACP         
Sponsors and Collaborators
Western Sydney Local Health District
Westmead hospital Westmead NSW 2145 Australia

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Responsible Party: Professor Michael Bourke, Professor of medicine, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT02470416     History of Changes
Other Study ID Numbers: HREC/14/WMEAD/226(4028)
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Professor Michael Bourke, Western Sydney Local Health District:
duodenal
ampulla

Additional relevant MeSH terms:
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Polyps
Adenoma
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms