NL-OMON53463招募中不适用
Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction. - TESLA RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
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
- 16 至 99（—）
入选标准
- •Written informed consent must be given according to ICH/GCP and
- •national/local regulations.
- •MHBO on imaging with histopathological confirmation or high clinical
- •Ineligible for surgical resection.
- •Hyperbilirubinemia (a combination of a total bilirubin level >50 mmol/l.
排除标准
- •Fluctuation or spontaneous decrease of a total bilirubin level before start
- •of any treatment suggesting a potential non-malignant diagnosis.
- •Patients who underwent previous biliary drainage procedures endoscopically or
- •percutaneously. Patients who underwent an attempted but failed ERCP are
- •eligible only when no papillotomy or cannulation was performed.
- •Clinical signs of cholangitis. Cholangitis is defined as the presence of both
- •fever (i.e. body temperature >38.5°C) and leucocytosis (i.e. >=10 *109/L)
- •without clinical or radiological evidence of acute cholecystitis (22).
- •Uncorrectable coagulation disorder.
- •Uncorrectable contrast allergy.
研究者
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