Hybrid Argon Plasma Coagulation (Hybrid-APC) for the treatment of Barrett*s esophagus with Low-Grade, High-Grade Intraepithelial Neoplasia or after Endoscopic Resection for Early Neoplasia - Prospective Multicenter study Hybrid-APC Barrett's esophagus neoplasia

Academisch Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•a) Patients in the age of 18-85 years
•b) Residual BE (defined as columnar lined esophagus with intestinal metaplasia) after prior ER (max 3 ER procedures) for HGD or mucosal cancer, irrespective if the residual BE harbors NDBE, LGD or HGD, OR patients with a BE without prior ER and a confirmed histological diagnosis of HGD or LGD.
•c) Written informed consent.

•a) BE with a C-value <1 or a C-value >10 cm
•b) Prior ER for G3/G4; L1; V1; R1 (vertical margin only) or submucosal invasion;
•c) Presence of endoscopically visible abnormalities at the time of initial APC treatment (additional ER is allowed);
•d) Presence of cancer in random biopsies obtained at the mapping endoscopy, 8-12 weeks before initial APC treatment;
•e) Pregnancy
•f) Patients in whom complete eradication is not considered a relevant treatment goal or in whom additional treatment is contraindicated;
•g) Patients in whom >80% of the BE has been resected by ER;
•h) Patients with incomplete wound healing 3 months post-ER despite adequate PPI-medication;
•i) Prior ablative therapy in the esophagus;
•j) Significant esophageal stenosis prior to initial APC treatment defined as a stenosis that can not be passed by a therapeutic endoscope or a stenosis that has been dilated endoscopically before.
•k) Presence of esophageal varices
•l) Anticoagulant therapy (apart from aspirin or NSAIDS) that can not be continued prior to APC or hemostatic disorders
•m) Life expectancy less than 1 year

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