NL-OMON56845尚未招募不适用
Primary percutaneous stenting of the bile ducts in patients with resectable perihilar cholangiocarcinoma - a pilot study - TESLA 2 pilot
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Written informed consent must be given according to ICH/GCP, and
- •national/local regulations.
- •Resectable pCCA on imaging with histopathological confirmation or high
- •clinical suspicion (as determined by the multidisciplinary hepatobiliary team).
- •Hyperbilirubinemia (a combination of a total bilirubin level >50 mmol/l.
- •Age above 18 years
排除标准
- •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 the presence of
- •both fever (i.e. body temperature >38.5°C) combined with leucocytosis (i.e. >=10
- •*109/L) without clinical or radiological evidence of acute cholecystitis
- •Uncorrectable coagulation disorder.
- •Uncorrectable contrast allergy.
研究者
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