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

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 112 人开始时间: 待定最近更新: 2024年4月15日

适应症

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•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 >20
•mmol/l, and/or jaundice and/or loss of appetite and/or dark urine and/or
•steatorrhea)

•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 *10^9/L) without clinical
•or radiological evidence of acute cholecystitis. Patients who underwent ERCP
•are eligible, providing no papillotomy was performed and there are no signs of
•cholangitis.

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