Endoscopic Biliary Stenting on Demand Versus Surgical Biliary Bypass for Palliation of Patients With Advanced Cancer of the Pancreatic Head: STENTBY - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Quality of life
研究概览
简要总结
The prognosis of patients with unresectable pancreatic cancer is dismal. Hence, palliation of tumor-associated symptoms, in particular jaundice due to low bile duct obstruction and gastric outlet obstruction, is the primary aim of these patients' care. Endoscopic stenting and surgical bypass are currently the two competing treatment options. There is currently no randomized trial comparing the recently developed metal stents to surgical bypass. Furthermore, there is very limited data on quality of life of these patients receiving either therapy. While endoscopic stenting represents the less invasive treatment, surgery may provide better long-term control requiring one-time treatment. Due to the incomplete evidence the present randomized controlled trial is designed to compare quality of life of patients undergoing endoscopic stenting on demand or surgical bypass for palliation of symptoms caused by cancer of the pancreatic head requiring with low bile duct obstruction.
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
- •Age equal or greater than 18 years
- •Diagnosis of unresectable cancer of the pancreatic head (after clinical, laboratory, radiological assessment) requiring palliative treatment for biliary obstruction. In unclear cases an exploratory laparotomy will be performed and resectability will be evaluated intraoperatively
- •Operability certified by anesthesiologist
- •Written informed consent
排除标准
- •Intervention technically/medically not feasible
- •Expected lack of compliance
- •One treatment option considered to be clearly in favor of the patient
研究组 & 干预措施
A
Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)
干预措施: Surgical bypass (Procedure)
B
Endoscopic biliary stenting using metal stent (completed by duodenal stent, if necessary)
干预措施: Endoscopic stenting (Procedure)
结局指标
主要结局
Quality of life
时间窗: 12 months
Serum bilirubin
时间窗: 12 months
次要结局
- Procedure-related complications(12 months)
