Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction (TESLA RCT)
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Major complications within 90 days after randomisation
研究概览
简要总结
The goal of this clinical randomized controlled trial is to perform primary percutaneous stenting (PPS) in patients with malignant hilar biliary obstruction (MHBO). The main question it aims to answer is:
To compare the efficacy of PPS above the ampulla to standard endoscopic biliary drainage (EBD) in patients with a MHBO who are ineligible for surgical resection.
Researchers will compare PPS with EBD to see if major complications within 90 days after randomisation occur.
Participants will undergo either primary percutaneous stenting or endoscopic biliary drainage, depending on randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
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 suspicion.
- •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.
研究组 & 干预措施
Endoscopic biliary drainage (standard of care)
干预措施: Endoscopic biliary drainage (Procedure)
Primary percutaneous stenting
干预措施: Primary percutaneous stenting (PPS) (Procedure)
结局指标
主要结局
Major complications within 90 days after randomisation
时间窗: 90 days after randomization
The primary objective is to compare major complications within 90 days after randomization of PPS and EBD in patients with MHBO who are ineligible for surgical resection. Major complications are defined as any complication leading to prolonged hospital stay of more than 72 hours, readmission to hospital, invasive reintervention, or death.
次要结局
未报告次要终点
研究者
Bas Groot Koerkamp, MD, PhD
MD, PhD
Erasmus Medical Center