NCT05122858已完成不适用
EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of participant with stent dysfunction (obstruction or migration) requiring endoscopic, radiological or surgical intervention
研究概览
简要总结
The main objective is to compare the EUS-BD with the insertion of a LAMS vs. traditional ERCP to restore biliary patency. Although ERCP has been the primary treatment for many years, it is associated with a significant risk of procedural complications and possible stent blockage. EUS-BD has been shown to be potentially safer and is associated with a lower risk of stent blockage. We seek with our study to determine whether EUS-BD may be the most effective treatment modality.
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
- •Radiological diagnosis (with or without pathological diagnosis) of a malignant obstruction of the borderline resectable distal bile ducts, locally advanced or unresectable distal to the hilum, at a minimum distance of 2 cm.
- •Resectability based on tumor staging after axial imaging and evaluation by a physician (surgeon, oncologist and / or gastroenterologist).
- •High results of the liver function test with a serum bilirubin level at least 3 times above the upper limit of normal (18.9 μmol / L)
- •Dilated extrahepatic bile duct measuring at least 1.2 cm in axial imaging, ultrasound or endoscopy.
- •Karnofsky index> 30%
- •ASA score <IV
- •Patient accepting the constraints of research
- •Patient affiliated or beneficiary of a social security scheme
- •Patient having signed an informed consent
排除标准
- •- Hilar obstruction (biliary obstruction located <2 cm from the hilum)
- •Coagulopathy and / or thrombocytopenia that cannot be corrected
- •Age <18 years old
- •Liver metastases involving> 30% of hepatic volume
- •Liver cirrhosis with portal hypertension or ascites
- •Biliary sphincterotomy or placement of a stent performed in the past
- •Anatomy modified by surgery
- •Common bile ducts measuring less than 1.2 cm will be excluded.
- •Patient with clinical and radiological signs of stenosis of the gastric outlet
- •Patient participating in another clinical study
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- •Pregnant, breastfeeding or parturient woman
- •Patient hospitalized without consent
研究组 & 干预措施
ERCP (Endoscopic Retrograde Cholangiopancreatography
Active Comparator
干预措施: ERCP (Procedure)
EUS guided biliary drainage
Experimental
干预措施: EUS guided biliary drainage (Procedure)
结局指标
主要结局
Number of participant with stent dysfunction (obstruction or migration) requiring endoscopic, radiological or surgical intervention
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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