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Clinical Trials/NCT00586872
NCT00586872
Completed
Not Applicable

Endoscopic Mucosal Resection in Barrett's Esophagus

Mayo Clinic1 site in 1 country1,000 target enrollmentOctober 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Barrett's Esophagus
Sponsor
Mayo Clinic
Enrollment
1000
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2007
End Date
June 4, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cadman Leggett

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (1)

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