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
- 1
- 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
研究组 & 干预措施
Artery first group
The basic principle of the "artery first" approach is the early identification of the SMA at its origin at the aorta with the further resection then being guided by its anatomic course.
The dissection is carried cephalad along the aorta until the origin of the SMA is reached. The posterior and right aspect of the SMA is then dissected over a few centimeters. On the right side of the SMA a replaced or accessory right hepatic artery, if present, will be identified and preserved. This maneuver should be done, if infiltration of the SMA is suspected as the procedure can be terminated at this point. Once the situation at the SMA is assessed and resectability is confirmed resection will be done.
干预措施: Artery first procedure (Procedure)
Conventional Group
A wide Kocher manoeuver is performed to fully mobilize the duodenum and the head of the pancreas. The colonic mesentery on the right side is separated from the anterior surface of the duodenum and the head of the pancreas. The size of the tumor and its relation to the superior mesenteric artery, the celiac trunk, the mesentery, the portal vein, and the superior mesenteric vein is assessed. If resectability is given a Kausch-Whipple's resection is performed.
干预措施: No artery first procedure (Procedure)
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)