No registrations found.
ID
Source
Health condition
Barrett's esophagus / Barrett slokdarm
Barrett's cancer / Barrett kanker
Barrett's neoplasia
Barrett's dysplasia
Radiofrequency ablation
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Study design
T=60: Single visit at 5-year follow up after the first treatment session.
Intervention
1. Endoscopic surveillance with biopsies according to the Seattle protocol;
2. EUS;
3. Endoscopic resection of the neosquamous epithelium.
Bldg. C2-210, Meibergdreef
J.J.G.H.M. Bergman
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
j.j.bergman@amc.uva.nl
Bldg. C2-210, Meibergdreef
J.J.G.H.M. Bergman
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
j.j.bergman@amc.uva.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2797 |
| NTR-old | NTR2938 |
| Other | METC AMC : 10/326 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
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)