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

June 28, 2023 updated by: Professor Michael Bourke

Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Michael Bourke

Investigators

  • Principal Investigator: Michael J Bourke, MBBS, Western Sydney Local Health District

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimated)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC 2014/5/4.3 (3972)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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