Simplified focal ablation RCT

Recruiting

Conditions: Barrett's esophagus / Barrett slijmvlies dysplasia in Barrett's esophagus / onrustige cellen in het Barrett slijmvliesRadiofrequency ablation / radiofrequente ablatieRFA

Registration Number: NL-OMON29446

Lead Sponsor: Academisch Medisch Centrum Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 72

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Complete endoscopic and histological remission of IM and dysplasia after 2 focal Barrx 90 ablation sessions.<br>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.<br>

Secondary Outcome Measures