|- candidate number||9733|
|- NTR Number||NTR2938|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-jun-2011|
|- Secondary IDs||10/326 METC AMC|
|- Public Title||5 year follow-up after treatment with radiofrequency ablation for Barrett's esophagus containing HGIN or early cancer.|
|- Scientific Title||Radiofrequency Ablation with or without Endoscopic Resection for Barrett’s Esophagus containing High-Grade Intraepithelial Neoplasia and/or Early Cancer: Durability of the Post-Treatment Neosquamous Epithelium at 5-year Follow-up.|
|- hypothesis||We hypothesize that radiofrequency ablation (RFA) is safe and effective after 5-year follow-up, for the eradication of Barrett's esophagus (BE) containing neoplasia.|
|- Healt Condition(s) or Problem(s) studied||Barrett's esophagus, Barrett's neoplasia, Barrett's cancer, Barrett's dysplasia, Radiofrequency ablation|
|- Inclusion criteria||1. All eligible patients treated with RFA (AMC-I/II, AMC-IV and EURO-I), according to the aforementioned study protocols, who are now being followed-up endoscopically in the AMC or referral centre within the Netherlands;|
2. Written informed consent.
|- Exclusion criteria||No justification for further follow-up due to (unrelated) comorbidity, or otherwise.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-apr-2011|
|- planned closingdate||1-mei-2012|
|- Target number of participants||55|
|- Interventions||1. Endoscopic surveillance with biopsies according to the Seattle protocol;|
3. Endoscopic resection of the neosquamous epithelium.
|- Primary outcome||1. Rate of complete histological remission of dysplasia and cancer at 5-yr follow-up;|
2. Rate of complete endoscopic and histological eradication of IM (including biopsies obtained from neosquamous mucosa) at 5-year follow-up.
|- Secondary outcome||1. Prevalence of subsquamous IM in neosquamous biopsies and ER-specimens;|
2. Prevalence of IM below the Neo Z-line during 5-year follow-up visits;
3. Adverse events.
|- Timepoints||T=60: Single visit at 5-year follow up after the first treatment session.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- 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 ||Academic Medical Center (AMC), Department of Hepato- and Gastroenterology|
(Source(s) of Monetary or Material Support)
|BÂRRX Medical Inc. Sunnyvale, California, US|
|- Publications||1. Gondrie JJ, Pouw RE, Sondermeijer CM, Peters FP, Curvers WL, Rosmolen WD, Ten KF, Fockens P, Bergman JJ. Effective treatment of early Barrett's neoplasia with stepwise circumferential and focal ablation using the HALO system. Endoscopy 2008;40:370-379;|
2. Gondrie JJ, Pouw RE, Sondermeijer CM, Peters FP, Curvers WL, Rosmolen WD, Krishnadath KK, Ten KF, Fockens P, Bergman JJ. Stepwise circumferential and focal ablation of Barrett's esophagus with high-grade dysplasia: results of the first prospective series of 11 patients. Endoscopy 2008;40:359-369.
3.Phoa KN, Pouw RE, van Vilsteren FG, Sondermeijer CM, Ten Kate FJ, Visser M, Meijer SL, van Berge Henegouwen MI, Weusten BL, Schoon EJ, Mallant-Hent RC, Bergman JJ.
Gastroenterology. 2013 Mar 28. pii: S0016-5085(13)00460-5 (Epub ahead of print)
|- Brief summary||The purpose of this project is to report on the 5-year outcomes of 4 previously published, IRB-approved, single-centre pilot trials (AMC-I/II/IV and EURO-I), evaluating long-term safety and efficacy of radiofrequency ablation for eradication of BE containing high-grade intraepithelial neoplasia or early cancer.|
|- Main changes (audit trail)|
|- RECORD||14-jun-2011 - 15-jun-2013|