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.
ID
Bron
Aandoening
Barrett's esophagus / Barrett slokdarm
Barrett's cancer / Barrett kanker
Barrett's neoplasia
Barrett's dysplasia
Radiofrequency ablation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Rate of complete histological remission of dysplasia and cancer at 5-yr follow-up;<br>
2. Rate of complete endoscopic and histological eradication of IM (including biopsies obtained from neosquamous mucosa) at 5-year follow-up.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
T=60: Single visit at 5-year follow up after the first treatment session.
Onderzoeksproduct en/of interventie
1. Endoscopic surveillance with biopsies according to the Seattle protocol;
2. EUS;
3. Endoscopic resection of the neosquamous epithelium.
Algemeen / deelnemers
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
Wetenschappers
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
No justification for further follow-up due to (unrelated) comorbidity, or otherwise.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2797 |
| NTR-old | NTR2938 |
| Ander register | METC AMC : 10/326 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
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)