The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer (Artery first)
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Baden-Württemberg
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Heidelberg、Baden-Württemberg、德国、69120
- 招聘中
- Department of General, Visceral and Transplantation Surgery, University of Heidelberg
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接触：
- Rahbari
- 邮箱：nuh.rahbari@med.uni-heidelberg.de
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Expected lack of compliance
- Impaired mental state or language problems
- patient having had neoadjuvant radiochemotherapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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. |
early identification of SMA to evaluate infiltration
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有源比较器：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.
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conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rate of R1 resections
大体时间：up to 1.5 years
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positive resection margins as described by the pathologists of the University of Heidelberg
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up to 1.5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Exploratory analyses
大体时间：up to 1.5 years
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Exploratory analyses of frequencies of complications and serious adverse events
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up to 1.5 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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