Long Term Barrett's Endoscopic Mucosal Resection Study (CBE)

June 28, 2023 updated by: Professor Michael Bourke

Long Term Outcomes of Patients Undergoing Endoscopic Resection of Barrett's Oesophagus (BO) With High Grade Dysplasia (HGD) and Early Adenocarcinoma

Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC).

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

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

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Endoscopy Unit
        • Contact:
        • Principal Investigator:
          • Michael J Bourke, MBBS
        • Sub-Investigator:
          • Farzan F Bahin, MBBS

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 or have had Barrett's Oesophagus with high grade dysplasia or adenocarcinoma.

Description

Inclusion Criteria:

  • 18 years or over
  • Have or have had Barrett's Oesophagus

Exclusion Criteria:

  • Do not have Barrett's Oesophagus
  • Have not had Barrett's Oesophagus resected at Westmead Hospital

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

Cohorts and Interventions

Group / Cohort
Post Barretts Excision
Patients who have undergone an EMR for Barretts Oesophagus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reviewing patients symptoms following resection
Time Frame: up to 3 years
Patients will be contacted via phone and will be required to answer questions over the phone. Health questionnaires may also be sent at the patients request to complete and post back.
up to 3 years

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

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 (Estimated)

October 1, 2021

Primary Completion (Estimated)

October 1, 2022

Study Completion (Estimated)

October 1, 2022

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimated)

July 25, 2014

Study Record Updates

Last Update Posted (Actual)

July 3, 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

  • HREC2013/10/6.2(3838)QA

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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