Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 29, 2014
Last verified: July 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: July 29, 2014
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
Barrett Esophagus
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 29, 2014