临床试验/NCT01569282

NCT01569282撤回不适用

Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study

Göteborg University6 个研究点分布在 1 个国家开始时间: 2011年10月1日最近更新: 2019年3月22日

适应症

干预措施

试验速览

阶段: 不适用
状态: 撤回
发起方
试验地点: 6
主要终点: Morbidity

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Preoperatively
•Patients with stent treated tumor in the pancreatic head or periampullary planned for pancreaticoduodenectomy
•The patient jaundice should have worn off and there should be no signs of duodenal obstruction
•The patient has given informed consent after verbal and written information in accordance with approved ethics application
•The patient has no anatomical conditions making endoscopic therapy impossible such as previous Billroth II or Gastric Bypass.
•Intraoperatively
•Peroperative findings of of carcinomatosis, metastases or local irresectability who oppose radical surgery
•Surgical double bypass should be technically feasible
•The patient has given informed consent after verbal and written information in accordance with approved ethics application

排除标准

•Peroperative signs of dysfunction on biliary stent
•Peroperative findings of gastric outlet obstruction
•Surgical double bypass not technically feasible

研究组 & 干预措施

Double bypass

Active Comparator

干预措施: Hepaticojejunostomy and gastroenterostomy (Procedure)

Stent Strategy

Active Comparator

干预措施: Stent strategy (Procedure)

结局指标

主要结局

Morbidity

时间窗: Day 1-30 after randomization

Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.

次要结局

Quality of life(Preop, 1 month postop and every third month)
Numbers of readmissions to hospital(Up to two years after the laparotomy)
The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions(Up to 24 months after the randomization)

研究者

发起方

Göteborg University

申办方类型

Other

责任方

Sponsor

研究点 (6)

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