A randomized trial comparing radiofrequency ablation with step-wise radical endoscopic resection for treatment of Barrett*s esophagus with high-grade dysplasia or early cancer.
- Conditions
- Barrett's oesophagusprecancerous condition of the esophagus1001799010017991
- Registration Number
- NL-OMON30042
- Lead Sponsor
- BARRx Medical Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
- Patients in the age of 18-85 years with HGD/EC in a Barrett*s esophagus.
- Pretreatment biopsies and ER specimen reviewed by the study pathologist (Prof. D. F. ten Kate).
- In case pretreatment diagnosis is made on biopsy material: biopsies should be obtained at two separate occasions of which the most recent occasion is less than six months prior to inclusion in the study.
- In case of previous endoscopic en-bloc resection of focal lesions: the ER specimen should have negative deeper resection margins and no invasive cancer at the lateral margins.
- In case of previous endoscopic piece meal resection of focal lesions: all ER specimens should have negative deeper resection margins and the patient should have had two separate endoscopies showing no residual invasive cancer in the remaining Barrett*s mucosa.
- Normal EUS
- Informed written consent.
- Patients with a Barrett*s segment >5 centimeters.
- Any endoscopic visual abnormality detected by high-resolution endoscopy at the RFA procedure.
- Invasive cancer in any of the biopsies obtained at two different mapping endoscopies after ER but before RFA.
- Any prior endoscopic treatment of Barrett*s neoplasia other than ER.
- Patients unable to give informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- total histological eradication of HGD and/or EC.<br /><br>- total endoscopic eradication of Barrett*s mucosa.<br /><br>- total histological eradication of Barrett*s mucosa.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- acute and late complications of RFA<br /><br>- Percentage regression of Barrett's mucosa on the surface.<br /><br>- Changes in 24 hour impedantie-measurments and micro-manometry.</p><br>