|- candidate number||21584|
|- NTR Number||NTR4994|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-jan-2015|
|- Secondary IDs||METC 2014_362 |
|- Public Title||Simplified focal ablation RCT|
|- Scientific Title||Randomized controlled trial comparing the simplified and standard regimen for focal radiofrequency ablation|
|- Healt Condition(s) or Problem(s) studied||Barrett's esophagus, Barrett's dysplasia, Radiofrequency ablation|
|- Inclusion criteria||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.
|- Exclusion criteria||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.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-jan-2015|
|- planned closingdate||1-jan-2017|
|- Target number of participants||72|
|- Interventions||Radiofrequency ablation with the BARRX90 device using either the simplified regimen or the standard regimen|
|- Primary outcome||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.
|- Secondary outcome||1. Total number of focal RFA sessions needed to reach complete remission of IM and dysplasia.
The protocol allows a total number of 3 focal RFA sessions.
2. Complete endoscopic and histological remission of IM and dysplasia after 3 focal RFA sessions with or without escape treatment.
At three months, the first post-treatment endoscopy will be performed with WLE and NBI, with 4-quadrant biopsies obtained from the neo-Z-line and from the neosquamous epithelium. Complete eradication of IM and neoplasia is defined as absence of IM and neoplasia, from neo-Z-line and neosquamous biopsies obtained after 3 focal RFA sessions and/or escape treatment with APC/ER.
3. Rate of esophageal stenosis requiring dilatation, occurring during the focal RFA treatment phase.
Any patient who requires a dilatation session after any of the Barrx 90 procedures, is considered as having an esophageal stenosis. The number of patients with stenosis are documented, and the number of dilatation procedures required to resolve the stenosis are documented.
4. Overall complications requiring admission/unplanned endoscopy.
Number and severity of acute (during the procedure), early (0-48 hours) and late (>48 hours) complications. Complications are only recorded if they are clinically significant and graded as ‘mild’ (unplanned hospital admission, hospitalization <3 days, hemoglobin drop <3 g/dL, no transfusion), ‘moderate’ (4-10 days hospitalization, <4 units blood transfusion, need for unplanned endoscopy), ‘severe’ (hospitalization >10 days, intensive care unit admission, need for surgery, >4 units of blood transfusion) or ‘fatal’ (death attributable to procedure <30 days or longer with continuous hospitalization).
5. Post-procedural pain immediately after RFA and after 2 days.
Post-procedural pain will be recorded using a visual-analogue scale (VAS) immediately after the procedure, as well as after two days by telephone follow-up.
6. Procedure time.
The following time points will be recorded to calculate total procedure time and treatment time: first introduction of the endoscope; first introduction of the Barrx 90 catheter; removal of the endoscope after finishing focal RFA treatment, including time to treat any acute complications occurring during the procedure.
|- Timepoints||6-8 weeks after RFA-treatment|
|- Trial web site||none|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||drs. Hannah Künzli |
|- CONTACT for SCIENTIFIC QUERIES||drs. Hannah Künzli |
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Netherlands
|- Main changes (audit trail)|
|- RECORD||16-jan-2015 - 3-apr-2015|