Preoperative biliary drainage for pancreato-biliary tumours causing obstructive jaundice: DRainage versus OPeratio

Academic Medical Centre (Netherlands)0 个研究点目标入组 210 人开始时间: 2005年12月20日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Clinical diagnosis of obstructive jaundice due to a pancreatic head or periampullary tumour
•2. A serum bilirubin level of greater than 40 µmol/l and less than 250 µmol/l at randomisation
•3. A spiral Computed Tomography (CT) scan according to standard protocol without metastases or local tumour ingrowth in the portal or mesenteric vessels of greater than 180°
•4. Referred for surgical treatment to one of the participating centres
•5. Time between CT and randomisation less than or equal to four days
•6. Informed consent

•1. Aged greater than 85 years or severe co-morbidity (Karnofsky less than 50%) and other contra-indications for major surgery
•2. Cholangitis/infection
•3. Previous ERCP and stenting or percutaneous biliary drainage
•4. Previous chemotherapy for this malignancy
•5. Severe gastric outlet obstruction (stenosis duodenum due to tumour growth) defined as vomiting, nausea and/or oral intake less than 1 l/day

发起方

Academic Medical Centre (Netherlands)