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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.


- candidate number3466
- NTR NumberNTR1337
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jun-2008
- Secondary IDsB-206 
- Public TitleA 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 TitleA multi-centre randomized trial comparing Radiofrequency Ablation with Radical Endoscopic Resection for treatment of Barrett's Esophagus with High-grade Dysplasia or Early Cancer.
- ACRONYMAMC-IV
- hypothesis
- Healt Condition(s) or Problem(s) studiedBarrett's esophagus, Barrett's neoplasia, Barrett's dysplasia, Intestinal metaplasia, Intraepithelial neoplasia
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2006
- planned closingdate1-okt-2008
- Target number of participants50
- InterventionsStepwise radical endoscopic resection (RER), or radiofrequency ablation (RFA)
- Primary outcome1. 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 outcome1. 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.
Follow-up
- 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 siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. J.J.G.H.M. Bergman
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.J.G.H.M. Bergman
- Sponsor/Initiator BRRX Medical Inc. Sunnyvale, California, US
- Funding
(Source(s) of Monetary or Material Support)
BRRX Medical Inc. Sunnyvale, California, US
- PublicationsN/A
- Brief summaryWe 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)
- RECORD12-jun-2008 - 25-jul-2008


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