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Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus

This study is currently recruiting participants.
Verified May 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586872
First received: December 21, 2007
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition
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:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

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)
Groups/Cohorts
1
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.

  Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts
Contact: Kenneth K Wang, MD 507-255-7495 barretts@mayo.edu
Contact: Lori S Lutzke 507-255-7495 lutzke.lori@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kenneth K Wang, MD     507-255-7495     wang.kenneth@mayo.edu    
Contact: Lori Lutzke     507-255-7495     lutzke.lori@mayo.edu    
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
  More Information

Additional Information:
research unit web site  This link exits the ClinicalTrials.gov site

No publications provided

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: May 17, 2013
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:
Adenocarcinoma
Adenocarcinoma, Mucinous
Barrett Esophagus
Esophageal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Digestive System Abnormalities
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2013