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Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla (OERDA)

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ClinicalTrials.gov Identifier: NCT02306603
Recruitment Status : Recruiting
First Posted : December 3, 2014
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

Brief Summary:
This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.

Condition or disease Intervention/treatment
Adenoma, Villous Procedure: Endoscopic Mucosal Resection

Detailed Description:
Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla is a safe and effective surgery sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the duodenum and ampulla.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla
Study Start Date : October 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
Endoscopic Mucosal Resection
Patients who are referred for Endoscopic Mucosal Resection of Duodenal and Ampullary Lesions will be included in this cohort.
Procedure: Endoscopic Mucosal Resection



Primary Outcome Measures :
  1. Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Analysis of the costs of this procedure compared to previous treatments [ Time Frame: 14 days ]
    Perform cost-utility analyses comparing different treatment approaches for duodenal and ampullary lesions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have Duodenal and ampullary adenomas which are amendable to Endoscopic Mucosal Resection
Criteria

Inclusion Criteria:

* Duodenal and ampullary lesion > 10mm

  • Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
  • Aged 18 years or older

Exclusion Criteria:

  • Lesion less than 10mm
  • Duodenal or ampullary lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
  • Aged younger than 18 years

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): NCT02306603


Contacts
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Contact: Rebecca Sonson, BN 98455555 ext 59779 Rebecca.Sonson@health.nsw.gov.au
Contact: Farzan F Bahin, MBBS 98455555 ext 56700 farzan.fahrtash@sydney.edu.au

Locations
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Australia, New South Wales
Westmead Hospital Endoscopy Unit Recruiting
Sydney, New South Wales, Australia, 2145
Contact: Rebecca Sonson, BN    98455555 ext 59779    Rebecca.Sonson@health.nsw.gov.au   
Contact: Michael J Bourke, MBBS    98455555 ext 56700    bec2153@gmail.com   
Sponsors and Collaborators
Professor Michael Bourke
Investigators
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Principal Investigator: Michael J Bourke, MBBS Western Sydney Local Health District

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT02306603     History of Changes
Other Study ID Numbers: HREC 2014/5/4.3 (3972)
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Adenoma
Adenoma, Villous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms