A 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
- 61
- 试验地点
- 2
- 主要终点
- Complications related to stent dysfunction
研究概览
简要总结
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.
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 as there will be better drainage of the obstructed biliary system with fewer adverse events.
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 85 Years（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).
结局指标
主要结局
Complications related to stent dysfunction
时间窗: 30 days
Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP)
次要结局
- Procedural complications(30 days)