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CBE: Long Term Barrett's Endoscopic Mucosal Resection Study

Sponsor
Professor Michael Bourke (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT02200250
Collaborator
(none)
200
Enrollment
1
Location
12
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Long Term Outcomes of Patients Undergoing Endoscopic Resection of Barrett's Oesophagus (BO) With High Grade Dysplasia (HGD) and Early Adenocarcinoma
    Anticipated Study Start Date :
    Oct 1, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Post Barretts Excision

    Patients who have undergone an EMR for Barretts Oesophagus

    Outcome Measures

    Primary Outcome Measures

    1. Reviewing patients symptoms following resection [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Westmead Endoscopy Unit Westmead New South Wales Australia 2145

    Sponsors and Collaborators

    • Professor Michael Bourke

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
    ClinicalTrials.gov Identifier:
    NCT02200250
    Other Study ID Numbers:
    • HREC2013/10/6.2(3838)QA
    First Posted:
    Jul 25, 2014
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Additional relevant MeSH terms:
    Barrett Esophagus

    Study Results

    No Results Posted as of Mar 23, 2021