|- candidate number||3466|
|- NTR Number||NTR1337|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-jun-2008|
|- Secondary IDs||B-206 |
|- Public Title||A multi-centre randomized trial comparing Radiofrequency Ablation with Radical Endoscopic Resection for treatment of Barrett's Esophagus with High-grade Dysplasia or Early Cancer.|
|- Scientific Title||A multi-centre randomized trial comparing Radiofrequency Ablation with Radical Endoscopic Resection for treatment of Barrett's Esophagus with High-grade Dysplasia or Early Cancer.|
|- Healt Condition(s) or Problem(s) studied||Barrett's esophagus, Barrett's neoplasia, Barrett's dysplasia, Intestinal metaplasia, Intraepithelial neoplasia|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2006|
|- planned closingdate||1-okt-2008|
|- Target number of participants||50|
|- Interventions||Stepwise radical endoscopic resection (RER), or radiofrequency ablation (RFA)|
|- Primary outcome||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 outcome||1. Acute and late complications of RER/RFA|
2. Percentage of surface regression of Barrett's epithelium
3. Costs of materials and procedures
|- Timepoints||- T= 0: inclusion: first RER/RFA.|
- T= 6 weeks: second RER/RFA.
- T=12 weeks: third RER/RFA.
- T=18 weeks: final RER/RFA.
- T=24 weeks: assessment of primary outcome parameters by endoscopy with lugol staining and biopsies.
- First year: every 6 months: endoscopy with lugol staining and biopsies below neo-squamocolumnar junction, residual Barrett's mucosa and neosquamous epithelium.
- From second year: annual endoscopy with lugol staining and biopsies below neo-squamocolumnar junction, residual Barrett's mucosa and neosquamous epithelium.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. J.J.G.H.M. Bergman|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. J.J.G.H.M. Bergman|
|- Sponsor/Initiator ||BÂRRX Medical Inc. Sunnyvale, California, US|
(Source(s) of Monetary or Material Support)
|BÂRRX Medical Inc. Sunnyvale, California, US|
|- Brief summary||We will perform a randomized trail comparing RER and RFA for the treatment of patients with Barrett's esophagus <5 cm containing high-grade dysplasia or early cancer, to investigate which treatment regimen is superior in terms of efficacy, early complication rate, late complication rate and the presence of buried Barrett's.|
|- Main changes (audit trail)|
|- RECORD||12-jun-2008 - 25-jul-2008|