Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Stent failure rate, and need for re-procedure before pancreaticoduodenectomy.
研究概览
简要总结
This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded.
This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resectable tumor of the head of the pancreas
- •Elevated serum bilirubin levels
- •Radiologically visible dilatation of the biliary system
排除标准
- •Distant metastasis
- •Inoperable tumor or other reason, why the patient is unfit for surgery
结局指标
主要结局
Stent failure rate, and need for re-procedure before pancreaticoduodenectomy.
时间窗: Evaluation at the day of pancreatic surgery
次要结局
- Other complications related to preoperative biliary decompression, and post-surgical complications(Complication emerged within 120 days from pancreaticoduodenectomy)
研究者
Leena Kylanpaa
Head of department
Helsinki University Central Hospital