EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 13
- 主要终点
- Effectiveness (Clinical success is defined as drop in bilirubin by 50%)
研究概览
简要总结
This research is being done to study the safety and feasibility of recruiting patients eligible for EUS-guided biliary drainage (EGBD). Our goal is to prospectively study safety and effectiveness of this procedure.
详细描述
Our central hypothesis is that EGBD is equally effective and safe to percutaneous transhepatic biliary drainage (PTBD) but is associated with better quality of life than PTBD in patients with inoperable malignant distal biliary obstruction who have failed prior ERCP. Furthermore, EGBD may be associated with decreased procedure-related costs. Patients who undergo PTBD usually require multiple procedures for stent exchange/upsize. Our initial study will be a prospective multicenter feasibility study that will include patients with inoperable distal biliary obstruction who have failed ERCP. If feasibility is demonstrated, our goal will be to compare EGBD and PTBD in a randomized multicenter international trial with a crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive adult patients (18-80 years of age) with jaundice due to inoperable (by EUS and/or CT criteria or due to health status) malignant distal (more than 2cm distal to hilum) biliary obstruction and who have failed prior ERCP attempt. Failure is considered to be 2 unsuccessful attempts, according to each institution's definition of "failed" procedure (patients may be consented for EGBD prior to repeat ERCP due to higher likelihood of failure). One failure at outside institution and one failure at your institution can be considered as total of two failures.
- •Ability to give informed consent
排除标准
- •Unable to give informed consent
- •Life expectancy < 1month
- •Pregnant or breastfeeding women
- •Acute gastrointestinal bleeding
- •Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), or on chronic anticoagulation
- •Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy.
- •Prior total gastrectomy, Roux-en-Y gastric bypass, esophagectomy and sleeve gastrectomy
- •ESLD with portal hypertension, varices, and/or ascites
- •Liver metastases burden > 30%
研究组 & 干预措施
EUS-guided biliary drainage
Patients in this arm will receive EUS-guided biliary drainage.
干预措施: EUS-guided biliary drainage (Other)
结局指标
主要结局
Effectiveness (Clinical success is defined as drop in bilirubin by 50%)
时间窗: From date of intervention up to 4 weeks
Clinical success is defined as drop in bilirubin by 50% at 2 weeks and to below 3 (level
次要结局
- Number of required procedures(From date of intervention up to death (These patients have a life expectancy of less than 2 years))
- Quality of life (QOL)(From date of intervention up to 12 weeks)
- Procedure-related costs(Lifetime (These patients have a life expectancy of less than 2 years))
- Determine safety of EGBD (Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis)(Lifetime (These patients have a life expectancy of less than 2 years))
- Stent patency(Lifetime (These patients have a life expectancy of less than 2 years))
- Technical success(Intra- and post intervention (These patients have a life expectancy of less than 2 years))
研究者
Mouen Khashab
Assistant Professor of Medicine; Director of Therapeutic Endoscopy
Johns Hopkins University