Quality of Life After Bilioenteric Anastomosis in Comparison to Endoscopically Placed Stents in Patients With Unresectable Pancreatic Cancer and Jaundice
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Outcome of Quality of Life.
研究概览
简要总结
To compare the quality of life (QoL) in patients receiving a bilioenteric anastomosis vs. endoscopical stenting for palliation of biliary obstruction due to locally unresectable or metastatic pancreatic cancer. In the past, endoscopy seems to have been favoured based on older studies, but with new chemotherapeutic regimens available, the likelihood to experience stent complications has increased. Therefore, the issue as to which palliation should be favoured has to be reconsidered.
详细描述
The aim of this multi-centre, prospective-randomised study was to compare the effectiveness of palliative applications on patients suffering from a local, advanced and/or hepatic, metastasising, non-resectable pancreas head carcinoma and jaundice.
Before randomisation, all patients are fitted with an endoscopically inserted biliary tract drainage endoscopically inserted. When postoperatively ascertained that the pancreas head carcinoma is non-resectable, the patient shall be electronically registered and randomly assigned to one of the palliative strategies. Group 1 will be fitted with a biliodigestive anastomosis. Group 2 will continue with the endoscopically inserted drainage. Regardless of which group they belong to, all patients will receive a palliative chemotherapy.
The primary parameter is the average quality of life over a period of 6 months post-operatively, to be analysed monthly using identical questionnaires. The comparison of the randomisation groups will be carried out using a co-variance analysis (ANCOVA) with the initial value, taken directly before the operation, to be used as co-variant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient with local, advanced adenocarcinoma of the pancreas head and jaundice.
- •Performance-status of 50 or above on the Karnofsky-scale (see attachment).
- •Adequate bone marrow reserves: leukocyte level > 3.5 x 10´/l, thrombocyte level level > 100 x 10/l; Haemoglobin> 80g/l.
- •Male or female patients, at least 18 years old.
- •Women of child bearing age must be sufficient protected against pregnancy (contraception) during and for 3 months after the end of the study.
排除标准
- •Adult patients with focal, advanced adenocarcinoma of the pancreas head and no jaundice; also no jaundice in their anamnesis and with no endoscopic retrograde cholangio-pancreaticography (ERCP)-induced intervention.
- •Breast feeding
- •Contra-indication for gemcitabine
结局指标
主要结局
Outcome of Quality of Life.
时间窗: 2 1/2 years
次要结局
- The incidence of surgical complications and complications, with regard to the endo-scopic stent insertion, are further aspects that shall be examined in this study.(2 1/2 years)