跳至主要内容
临床试验/NCT00753441
NCT00753441终止不适用

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

Heidelberg University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年2月1日最近更新:
适应症
干预措施

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

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

Experimental

Surgical bypass (choledochojejunostomy, in combination with gastroenterostomy if necessary)

干预措施: Surgical bypass (Procedure)

B

Active Comparator

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuh Rahbari

MD

Heidelberg University

研究点 (2)

Loading locations...

相似试验