ID
Bron
Verkorte titel
Aandoening
Barrett's esophagus / Barrett slijmvlies
dysplasia in Barrett's esophagus / onrustige cellen in het Barrett slijmvlies
Radiofrequency ablation / radiofrequente ablatie
RFA
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Complete endoscopic and histological remission of IM and dysplasia after 2 focal Barrx 90 ablation sessions.
Complete endoscopic eradication of IM is defined as no suspicion on residual tongues or islands of IM. If there is suspicion on residual IM, the end-point is not reached and additional RFA treatment can be performed, without taking biopsies. Complete histological eradication of IM and neoplasia is defined as absence of IM and/or neoplasia, from neo-Z-line and neosquamous biopsies obtained after 2 focal RFA sessions.
Achtergrond van het onderzoek
Netherlands
Belgium (Leuven)
Onderzoeksopzet
6-8 weeks after RFA-treatment
Onderzoeksproduct en/of interventie
Radiofrequency ablation with the BARRX90 device using either the simplified regimen or the standard regimen
Publiek
Hannah Künzli
Meibergdreef 9, C2-231
Amsterdam 1105 AZ
The Netherlands
+31-205665584
h.t.kunzli@amc.uva.nl
Wetenschappelijk
Hannah Künzli
Meibergdreef 9, C2-231
Amsterdam 1105 AZ
The Netherlands
+31-205665584
h.t.kunzli@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients aged 18-85 years.
2. BE with biopsy proven LGD, HGD or EC confirmed after local expert pathology review, with residual endoscopically visible Barrett’s mucosa, with or without prior ER and/or circumferential RFA.
3. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Significant esophageal stenosis prior to the first focal RFA treatment, preventing passage of a therapeutic endoscope OR any prior endoscopic dilatation for esophageal stenosis.
2. Presence of esophageal varices.
3. Anti-coagulant therapy (apart from aspirin or NSAID) that cannot be discontinued prior to ER or RFA, OR uncorrectable hemostatic disorders.
4. In case of prior ER: a specimen showing carcinoma with positive vertical resection margins, deep submucosal invasion (>T1sm1), poorly or undifferentiated cancer (G3 or G4), or lymphatic/vascular invasion.
5. In case of prior ER: invasive cancer in any of the biopsies obtained at high-resolution endoscopy after ER.
6. Patients unable to give informed consent.
7. No justification for further treatment due to (unrelated) comorbidity.
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 | NL4740 |
| NTR-old | NTR4994 |
| Ander register | : METC 2014_362 |