Simplified focal ablation RCT

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.

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.