Bile Duct Drainage After ERCP Failure: EUS-guided Biliary Versus Percutaneous Transhepatic Drainage
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Complications of PTBD vs EUS-BD
研究概览
简要总结
The vast majority of patients with distal biliary, pancreatic head or uncinate process cancer have jaundice caused by distal malignant obstruction (DMO) of the common bile duct. Biliary drainage by Endoscopic Retrograde Cholangiopancreatography (ERCP) with trans-papillary stent placement is the treatment of choice.
ERCP has a failure rate ranging from 12 - 25 percent. Percutaneous transhepatic biliary drainage (PTBD) is the alternative conventional way to drain the biliary tree after ERCP failure, which is related with substantial morbidity (62%) and mortality (17%). Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) is a novel promising drainage modality with reported excellent outcomes in terms of clinical success and complications.
The implementation of EUS-BD besides ERCP and PTBD into Dutch daily clinical practice raises many questions related to performance, costs, QoL, training, implementation and overall oncological treatment success. This structured learning/proctoring program with an additional national registry provides insights into EUS-BD and how to implement EUS-BD in the Dutch standard of care.
详细描述
The study is designed as a prospective multicenter registry. The data obtained in this study will enable the EUS-BD procedure to progress to larger multicenter and preferably randomized control trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years and older
- •Distal malignant CBD obstruction (from ampulla to 1cm distal to the hilum)
- •Indication for biliary drainage after failed ERCP-guided biliary drainage
排除标准
- •Previous PTBD and/or EUS-BD
- •Inability to provide informed consent
- •Pregnancy
- •American Society of Anesthesiology (ASA) Grade IV-V
结局指标
主要结局
Complications of PTBD vs EUS-BD
时间窗: 180 days
The primary outcome measure is a composite of severe complications occurring within 180 days following inclusion, analyzed by intention to treat. Complications we score are: bleeding, perforation, biliary leak, biliary peritonitis, abscess, haemobilia, stent occlusion, cholangitis, pancreatitis, anesthesia related complications, severe post-procedural pain, drain/stent dysfunction, cutaneous fistula, stent migration and drain leakage or dislocation.
次要结局
- Stent/drain patency(180 days)
- Technical success of the initial procedure(180 days)
- Clinical success(180 days)
- Treatment delay(180 days)
- Effect of EUS-BD and PTBD on the difficulty of surgery.(180 days)
- Length of hospital stay(180 days)
- Time to re-intervention and number of re-interventions(180 days)
- Successful training(180 days)