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 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•- 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.

发起方

BARRx Medical Inc