Primary percutaneous placement of metal stents for palliative biliary drainage in patients with a primary malignant perihilar stricture

Erasmus MC0 个研究点目标入组 37 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•In order to be eligible to participate in this study, a subject must meet the following criteria:
•Written informed consent must be given according to ICH/GCP, and national/local regulations.
•Unresectable primary malignant perihilar obstruction on imaging with histopathological confirmation or high clinical suspicion (as determined by the multidisciplinary hepatobiliary team)
•Symptomatic hyperbilirubinemia (a combination of a total bilirubin level >100 mmol/l, and/or jaundice and/or loss of appetite and/or dark urine and/or steatorrhea)
•Age > 70 years

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Fluctuation or spontaneous decrease of a total bilirubin level before start of any treatment suggesting potential benign origin.
•Patients who underwent previous drainage procedures endoscopically or percutaneously with an internalized biliary catheter.
•Clinical signs of cholangitis. Cholangitis was defined as both fever (i.e. body temperature >38.5°C) and leucocytosis (i.e. =10 *109/L) without clinical or radiological evidence of acute cholecystitis (14). Patients who underwent ERCP are eligible, providing no papillotomy was performed or stent was placed and there are no signs of cholangitis.

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