Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Complications related to stent dysfunction
研究概览
简要总结
Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression
详细描述
Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
- •Patients 19 yrs of age and older
- •Serum bilirubin > 2mg/dl
- •CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).
排除标准
- •Karnofsky score < 60
- •Prior (ERCP or PTC) attempts at biliary decompression for the same indication
- •Tumor-related gastric outlet obstruction (vomiting and oral intake of < 1L/day)
- •Ongoing or planned neoadjuvant therapy
- •Cholangitis at presentation or coagulopathy needing reversal medication
- •Post-surgical anatomy
- •Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
- •Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).
研究组 & 干预措施
Metal stent
Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.
干预措施: Stent Dysfunction (Procedure)
Metal stent
Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.
干预措施: Complications (Procedure)
Plastic Stent
At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.
干预措施: Stent Dysfunction (Procedure)
Plastic Stent
At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.
干预措施: Complications (Procedure)
结局指标
主要结局
Complications related to stent dysfunction
时间窗: 30 days
Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.
次要结局
- Procedural complications(30 days)