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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02306603
Recruitment Status : Recruiting
First Posted : December 3, 2014
Last Update Posted : March 23, 2021
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 2021
Estimated Study Completion Date : October 2022

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT02306603

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Contact: Kathleen Goodrick, BN 88905555

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Australia, New South Wales
Westmead Hospital Endoscopy Unit Recruiting
Sydney, New South Wales, Australia, 2145
Contact: Kathleen Goodrick, BN    88905555   
Contact: Michael J Bourke, MBBS   
Sponsors and Collaborators
Professor Michael Bourke
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Principal Investigator: Michael J Bourke, MBBS Western Sydney Local Health District
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District Identifier: NCT02306603    
Other Study ID Numbers: HREC 2014/5/4.3 (3972)
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Adenoma, Villous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type