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. - Radiofrequency ablation vs SRER-study

BARRx Medical Inc0 sites40 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

BARRx Medical Inc

•\- 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.