NCT03821025Unknown不适用
Treatment of Malignant Distal Biliary Obstruction - a Randomized Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of patients without stent failure
研究概览
简要总结
A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18years of age or older
- •informed consent obtained after oral and written information
- •clinical data in accordance with a malignant bile duct obstruction
- •imaging evidence: (ultrasonography (US), computed tomography (CT) or magnetic resonance imaging (MRI) shows signs of extrahepatic malignant common bile duct obstruction
- •typical ERCP findings of a malignant common bile duct stenosis
- •proximal margin of the bile duct stenosis ≥2 cm from the hepatic confluence
- •bilirubin > 50 micromol/L
- •radical surgery not deemed possible
排除标准
- •patients with active hepatitis or other jaundice-causing hepatic diseases
- •informed consent not obtained or patient unable to give informed consent
- •patients with no understanding of English, Afrikaans or Xhosa where it is not possible to obtain informed consent
- •metastasis with multiple significant intrahepatic stenosis causing blockage of one or more segments of the liver (liver metastasis otherwise not an exclusion criteria)
- •the patient is a possible candidate for surgical resection
- •suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations)
- •the proximal end of the stenosis is < 2 cm from the hepatic confluence
- •previous BII or Roux-en-Y gastric reconstruction
- •significant duodenal obstruction making ERCP difficult
- •previous bile duct stent
研究组 & 干预措施
Multiple Plastic Stents
Active Comparator
Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture.
干预措施: Biliary stent (Device)
Self-expandable Metal Stents
Active Comparator
Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture
干预措施: Biliary stent (Device)
结局指标
主要结局
Number of patients without stent failure
时间窗: 12 months
Number of patients without Stent failure (jaundice) or death with a patent stent
次要结局
- Stent deployment failure(During procedure)
- Cost(12 months)
- Overall survival(12 months)
研究者
Marc Bernon
Senior consultant
University of Cape Town
研究点 (2)
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