Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation
- Conditions
- Barrett's Esophagus
- Interventions
- Genetic: response to therapy
- Registration Number
- NCT01568723
- Lead Sponsor
- Mayo Clinic
- Brief Summary
The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.
- Detailed Description
This Project is designed to identify biologically-based and clinically-useful biomarkers of tissue at risk for neoplastic progression as well as of response to ablation therapy. These results will result in improved risk stratification in BE and better targeting of resources for patients who are candidates for ablative therapy, while simultaneously providing key information regarding the origins of Barrett's esophagus.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- Barrett's esophagus with high grade dysplasia or intramucosal (early) adenocarcinoma.
- BE length ≥ 2 cm and ≤ 8 cm.
- Able to return every 3 months for one year after ablation
- Patients who are unable to be compliant with follow-up endoscopies
- patients who cannot tolerate Proton Pump inhibitors
- pre-existing esophageal strictures
- pregnant or nursing women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Radiofrequency ablation response to therapy participants with barrett's esophagus with high grade dysplasia who undergo radiofrequency ablation (RFA)
- Primary Outcome Measures
Name Time Method Response to therapy one year post ablation evaulation will be made at 3 month intervals for one year post ablation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of Pennsylvania Perelman School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Columbia University
🇺🇸New York, New York, United States