Preoperative Endoscopic Biliary Drainage With Self Expanding Metal Stents (SEMS) vs. Direct Surgical Resection for Patients With Severe Obstructive Jaundice
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Complication Rates of Grade III or Higher
研究概览
简要总结
This trial studies the side effects of self expanding metal stent (SEMS) placement before surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with severe obstructive jaundice. SEMS placement unblocks the bile duct and may help in improving bile drainage prior to surgery in patients with periampullary pancreatic cancer with severe obstructive jaundice.
详细描述
PRIMARY OBJECTIVES:
I. To compare the 30-day overall complication rates between patients with severe obstructive jaundice undergoing preoperative endoscopic biliary drainage with self expanding metal stents (SEMS) and patients undergoing direct surgical resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of operable peri-ampullary pancreatic cancer as determined by the Department of Surgery per their standard of care
- •Serum bilirubin > 10 mg/dl
- •Adequate birth control
排除标准
- •Patients with evidence of distant metastasis on computed tomography (CT) or magnetic resonance imaging (MRI)
- •Patients anticipated to require vascular reconstruction
- •Patients with cholangitis
- •Patients for whom surgery is deemed inappropriate by surgeon
- •Patients with bilirubin less than 10 mg/dL or greater than 20 mg/dL
- •Patients who previously underwent biliary decompression for cholangitis by ERCP or percutaneous transhepatic cholangiography (PTC)
- •Patients with low performance score (Karnofsky performance status scale < 50)
- •Patients with known preexisting liver disease with associated elevated bilirubin
- •Patients who are pregnant or actively breast feeding
研究组 & 干预措施
Standard of care surgical resection
Patients undergo standard of care surgical resection.
干预措施: Standard of care (Other)
SEMS
Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.
干预措施: Endoscopic Retrograde Cholangiopancreatography (Procedure)
结局指标
主要结局
Complication Rates of Grade III or Higher
时间窗: At 30 days post-surgery
The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.
Intraoperative Estimated Blood Loss
时间窗: At time of surgery
Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.
次要结局
未报告次要终点