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Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus

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ClinicalTrials.gov Identifier: NCT00586872
Recruitment Status : Enrolling by invitation
First Posted : January 7, 2008
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic

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
Barrett's Esophagus Early Esophageal Adenocarcinoma

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Group/Cohort
1
patients with barretts esophagus and/or early esophageal adenocarcinoma who have undergone endoscopic mucosal resection



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 [ Time Frame: 3 months after EMR procedure ]
    analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who have had endoscopic mucosal resection
Criteria

Inclusion Criteria:

  • Barrett's Esophagus Early Esophageal Adenocarcinoma History of Endoscopic Mucosal Resection

Exclusion Criteria:


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 ClinicalTrials.gov identifier (NCT number): NCT00586872


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kenneth K Wang, MD Mayo Clinic

Additional Information:
Responsible Party: Kenneth K. Wang, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586872     History of Changes
Other Study ID Numbers: 07-007063
07-007063 ( Other Identifier: Mayo Clinic IRB )
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Keywords provided by Kenneth K. Wang, Mayo Clinic:
Barrett's Esophagus
Early Esophageal Adenocarcinoma
Endoscopic Mucosal Resection

Additional relevant MeSH terms:
Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms