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Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00586872
Collaborator
(none)
1,800
Enrollment
1
Location
216
Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Existing records will be reviewed to evaluate the predictors of complications including stricture formation, bleeding or perforation associated with endoscopic mucosal resection

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Barrett's esophagus (BE) is a complication of gastroesophageal reflux disease in which the normal squamous lining of the esophagus is replaced by specialized columnar epithelium.1 Approximately 5%-10% of patients diagnosed with BE are thought to be at risk of developing esophageal adenocarcinoma.2 Patients with high-grade dysplasia (HGD) on biopsy are at the greatest cancer risk³. EMR is being performed clinically in our Barrett's Esophagus Unit on a regular basis during endoscopy for patients with Barrett's Esophagus and/or early esophageal adenocarcinoma. There are two predominant endoscopic mucosal resection (EMR) techniques exist using FDA approved devices - the EMR cap method using a transparent cap/snare combination and the endoscopic variceal ligation method using a band ligator/snare combination to resect tissue.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Endoscopic Mucosal Resection in Barrett's Esophagus
    Study Start Date :
    Oct 1, 2007
    Anticipated Primary Completion Date :
    Oct 1, 2025
    Anticipated Study Completion Date :
    Oct 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    1

    patients with barretts esophagus and/or early esophageal adenocarcinoma who have undergone endoscopic mucosal resection

    Outcome Measures

    Primary Outcome Measures

    1. Number and types of adverse events in participants who have undergone endoscopic mucosal resection with documented adverse events will be evaluated for predictors of complications [3 months after EMR procedure]

      analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Barrett's Esophagus Early Esophageal Adenocarcinoma History of Endoscopic Mucosal Resection
    Exclusion Criteria:
    • NA

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Kenneth K Wang, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Kenneth K. Wang, MD, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT00586872
    Other Study ID Numbers:
    • 07-007063
    • 07-007063
    First Posted:
    Jan 7, 2008
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021
    Keywords provided by Kenneth K. Wang, MD, Mayo Clinic
    Barrett's Esophagus
    Early Esophageal Adenocarcinoma
    Endoscopic Mucosal Resection
    Additional relevant MeSH terms:
    Adenocarcinoma
    Barrett Esophagus

    Study Results

    No Results Posted as of Dec 15, 2021