Randomized controlled trial comparing the simplified and standard regimen for focal radiofrequency ablatio

Completed

Conditions: dysplasia in Barrett's esophagus
dysplastic Barrett mucosa
10017990

Registration Number: NL-OMON42316

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

1. Patients aged 18-85 years.
2. BE with biopsy proven LGD, HGD or EC confirmed after 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
<p>1. Complete endoscopic and histological remission of IM and dysplasia after 2<br /><br>focal Barrx 90 ablation sessions.<br /><br>Complete endoscopic eradication of IM is defined as no suspicion on residual<br /><br>tongues or islands of IM. If there is suspicion on residual IM, the end-point<br /><br>is not reached and additional RFA treatment can be performed, without taking<br /><br>biopsies. Complete histological eradication of IM and neoplasia is defined as<br /><br>absence of IM and/or neoplasia, from neo-Z-line and neosquamous biopsies<br /><br>obtained after 2 focal RFA sessions.</p><br>

Secondary Outcome Measures