EUS-Guided Biliary Drainage in Patients with Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial

All India Instittue of Medical Sciences0 个研究点目标入组 20 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Consecutive adult patients (18-80 years of age) with jaundice due to inoperable (by EUS and/or CT criteria or due to health status) malignant distal (more than 2cm distal to hilum) biliary obstruction and who have failed prior ERCP attempt. Failure is considered to be 2 unsuccessful attempts, according to each institutionâ??s definition of â??failedâ?? procedure (patients may be consented for EGBD prior to repeat ERCP due to higher likelihood of failure). One failure at outside institution and one failure at our institution can be considered as total of two failures.
•2.Ability to give informed consent

•1.Unable to give informed consent
•2.Life expectancy < 1month
•3.Pregnant or breastfeeding women
•4.Acute gastrointestinal bleeding
•5.Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), on chronic anticoagulation, or platelet count <50,000
•6.Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy
•7.Prior total gastrectomy, Roux-en-Y gastric bypass, esophagectomy and sleeve gastrectomy
•8.Cirrhosis with portal hypertension, varices, and/or ascites
•9.Liver metastases burden > 30%

发起方

All India Instittue of Medical Sciences