The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Rate of R1 resections
研究概览
简要总结
To show whether the artery first approach leads to equal or less rate of positive resection margins in pancreatic head cancer than the standard technique (ppWhipple only with standard Kocher's manoeuvre)
详细描述
This is a prospective non-randomized trial with two study groups. The trial is designed to show if the ARTERY FIRST approach reduces the rate of R1 resections in patients undergoing surgery for cancer of the pancreatic head.
After the diagnosis of cancer of the pancreatic head by clinical, laboratory and imaging evaluation patients who are scheduled for resection will be screened for inclusion into the trial. Informed consent is obtained at least on the day before surgery and patients meeting the eligibility criteria will be enrolled into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Pancreatic head cancer (diagnosis by clinical, laboratory and radiological evaluation)
- •Patients scheduled for curative resection
- •No evidence of distant metastases
- •Age equal or greater than 18 years
- •Informed consent
排除标准
- •Expected lack of compliance
- •Impaired mental state or language problems
- •patient having had neoadjuvant radiochemotherapy
结局指标
主要结局
Rate of R1 resections
时间窗: up to 1.5 years
positive resection margins as described by the pathologists of the University of Heidelberg
次要结局
- Exploratory analyses(up to 1.5 years)