Barrett esophagus
Conditions
Interventions
Stepwise radical endoscopic resection (RER), or radiofrequency ablation (RFA)
Sponsors
BÂRRX Medical Inc.
540 Oakmead Parkway
Sunnyvale, CA 94085
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with biopsy proven HGD or EC in a Barrett's esophagus in at least 2 endoscopic procedures prior to randomization, of which the last was within 3 months of randomization. 2. Age between 18 and 85 years. 3. Type I, IIa, IIb or IIc lesions 4. Maximum size of visible lesions: length < 3 cm, circumferential extend <50%. 5. No signs of deep submucosal infiltration on endoscopic inspection and EUS. 6. No signs of metastatic disease on endoscopic ultrasound (EUS) or CT-scan of thorax and abdomen (CT is only required for those with cancer in biopsies or EMR specimens). 7. Informed written consent.
Exclusion criteria
Exclusion criteria: 1. Length of Barrett's esophagus > 5 cms. 2. Deep submucosal infiltration („dT1sm2) in the endoscopic resection specimen. 3. Significant stenosis (not allowing passage of a therapeutic endoscope) after the initial EMR and prior to RFA. 4. Presence of invasive cancer in biopsies prior to RFA. 5. Patients unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Rate of total histological eradication of HGD and/or EC 2. Rate of total endoscopic eradication of Barrett's mucosa 3. Rate of total histological eradication of Barrett's mucosa | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acute and late complications of RER/RFA 2. Percentage of surface regression of Barrett's epithelium 3. Costs of materials and procedures | — |
Contacts
Public ContactJ.J.G.H.M. Bergman
Academic Medical Center Bldg. C2-210, Meibergdreef
Outcome results
None listed