Endoscopic Ultrasound-Guided Biliary Drainage (EUS-BD) Compared to Standard Transpapillary Biliary Drainage (ERCP-TP) for Palliation of Jaundice in Unresectable Cancer of the Head of the Pancreas (BILPAL TRIAL)
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Efficacy of Stent Patency
研究概览
简要总结
This Endoscopic Ultrasound guided Biliary Drainage (EUS-BD) vs. Endoscopic Retrograde Cholangiopancreatography (ERCP-TP) trial (BILPAL) is a randomized controlled multicenter trial that will provide evidence whether or not traditional ERCP biliary drainage is to be performed in patients with obstruction in bile duct due to unresectable pancreatic head or periampullary tumor.
详细描述
Obstructive jaundice is the most common symptom in patients with periampullary cancer and cancer of the pancreatic head. For patients with unresectable tumors, palliation of malignant obstructive is traditionally achieved using endoscopic retrograde cholangiopancreatography (ERCP) with transpapillary (TP) stent placement. Data show that ERCP is equivalent to surgery with regards to relief of jaundice. Self-expandable metal stents (SEMS) offer prolonged palliation compared to large-bore (10Fr) plastic stents. However, it is believed that gastric outlet obstruction occurs more commonly in patients who have received SEMS for palliation of MOJ. In addition, ERCP is associated with adverse events including pancreatitis, post-sphincterotomy bleeding, and perforation.
More recently endoscopic ultrasound (EUS)-guided biliary drainage has been described for biliary drainage in patients with malignant distal bile duct obstruction. Thus far it has been used as a rescue approach when traditional ERCP-guided transpapillary biliary drainage ERCP fails. TP failure can occur as a result of duodenal obstruction, failed cannulation, and failed wire access across the stricture.
Potential advantages of EUS-guided biliary drainage include avoidance of pancreatitis and post-sphincterotomy bleeding. Additionally, it may result in a lower frequency of gastric outlet obstruction since the stent does not encroach upon the tumor.
To compare the potential advantages of EUS-guided biliary drainage the investigators are conducting a multicenter, randomized trial comparing the EUS-guided drainage to traditional ERCP.
This EUS-BD vs. ERCP-TP-trial (BILPAL) is a randomized controlled multicenter trial that will provide evidence whether or not traditional ERCP biliary drainage is to be performed in patients with obstruction in bile duct due to unresectable pancreatic head or periampullary tumor.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 90 years old
- •Clinically indicated for biliary endoscopic drainage with Endoscopic Ultrasound guidance or ERCP
- •CT scan has demonstrated a lesion in the pancreatic head area with metastases and/ or local tumor ingrowth preventing resection.
- •CT with evidence of distant metastases or local tumor ingrowth into portal or mesenteric vessels (as defined by the tumor surrounding the vessel for at least 180 degrees of the circumference)
- •A serum bilirubin level of > 2.5mg/dL at randomization
- •Deemed surgically unresectable
- •Consents to participation in the randomized controlled trial
- •Exclusion Criteria :
- •> 90 years
- •Severe comorbidity (Karnofsky <50%)
- •Any prior successful previous biliary drainage including ERCP and stenting, percutaneous biliary and surgical,
- •Prior surgically altered pancreaticobiliary or gastroduodenal anatomy.
- •Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
- •Currently participating in another device trial that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
排除标准
- 未提供
结局指标
主要结局
Efficacy of Stent Patency
时间窗: 6 months after randomization
Efficacy is measure by the evaluation of biliary stent patency at month 6 post randomization
次要结局
- Quality of Life(1 year from study enrollment)
- Serum bilirubin decrease(1 month from procedure)
- Safety evaluation: Assessment of number and frequency of procedure related adverse events within 1 month of the procedure(Within 1 month of procedure)
- Clinical Success(1 month from procedure)
- Technical Success(1 month from procedure)
- Survival duration(2 years from randomization)
研究者
Michel Kahaleh
Chief of Endoscopy
Weill Medical College of Cornell University