Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
First received: December 21, 2007
Last updated: December 15, 2015
Last verified: December 2015
Existing records will be reviewed to evaluate the predictors of complications including stricture formation, bleeding or perforation associated with endoscopic mucosal resection

Barrett's Esophagus
Early Esophageal Adenocarcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Endoscopic Mucosal Resection in Barrett's Esophagus

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: October 2007
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
patients with barretts esophagus and/or early esophageal adenocarcinoma who have undergone 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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who have had endoscopic mucosal resection

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00586872

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

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 
Study First Received: December 21, 2007
Last Updated: December 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Barrett's Esophagus
Early Esophageal Adenocarcinoma
Endoscopic Mucosal Resection

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

ClinicalTrials.gov processed this record on May 26, 2016