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Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Kenneth K. Wang, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586872
First received: December 21, 2007
Last updated: December 15, 2015
Last verified: December 2015

December 21, 2007
December 15, 2015
October 2007
October 2017   (final data collection date for primary outcome measure)
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 ]
analysis
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Complete list of historical versions of study NCT00586872 on ClinicalTrials.gov Archive Site
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Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Endoscopic Mucosal Resection in Barrett's Esophagus
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 (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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample
patients who have had endoscopic mucosal resection
  • Barrett's Esophagus
  • Early Esophageal Adenocarcinoma
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1
patients with barretts esophagus and/or early esophageal adenocarcinoma who have undergone endoscopic mucosal resection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
900
October 2017
October 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00586872
07-007063, 07-007063
No
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Kenneth K. Wang, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Kenneth K Wang, MD Mayo Clinic
Mayo Clinic
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP