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临床试验/NCT03714542
NCT03714542已完成不适用

Prospective Evaluation of the Role of MRI in the Perioperative Management of Pancreas Adenocarcinomas

University of Lausanne Hospitals2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Evaluation of the MRI precision in the delimitation of circumferential resection margins

研究概览

简要总结

The precision of MRI has improved over the past few years, in particular for the hepatobiliary and pancreatic pathologies. The role of MRI in the management of operated pancreas tumors remains nevertheless unclear and few studies have compared MRI to the actual gold standard (CT). Compared to CT, MRI is not only a morphologic imaging technique but also a functional imaging technique. MRI could therefore evaluate in a non-ionizing and dynamic way several important pre- and postoperative aspects after pancreaticoduodenectomy (PD). This study on the perioperative role of MRI includes 3 parts:

First, CT is known to minimize the real size of the pancreatic tumors and to underestimate the vascular invasion correlated to resectability. The preoperative determination of the resection surgical margins could be improved thanks to the high-contrast resolution of MRI.

Moreover, PD is a complex surgery encompassing a fragile anastomosis between the pancreatic parenchyma and the digestive tract. The permeability of the pancreatic anastomosis after PD remains presently unknown and has not been correlated to the clinical state of the patient. MRI associated with secretin injection allows evaluating this permeability, which cannot be done by CT due to the absence of functional evaluation.

Finally, present radiological follow-up after PD for tumors of the pancreatic head is performed with CT. The MRI performance has not been demonstrated yet in the context of follow-up. This imaging modality nevertheless offers unique specificities that are very interesting and that could be helpful for the diagnosis of recurrence.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • patients over 18 years old
  • indication for a PD for a resectable adenocarcinoma of the pancreatic head.

排除标准

  • chronic pancreatitis
  • absence of discernment
  • patients not speaking French
  • preoperative radio/chemotherapy
  • patients with claustrophobia
  • patients with metallic implants.

结局指标

主要结局

Evaluation of the MRI precision in the delimitation of circumferential resection margins

时间窗: Preoperative MRI performed up to one month before the operation date.

The preoperative MRI results will be compared to the anatomopathological results.

次要结局

  • Evaluation of the potential correlation between the tumor size and the resection margins.(Preoperative MRI performed up to one month before the operation date.)
  • Determination of the pancreatic anastomosis permeability(One year after the operation)
  • Determination of the rate of exocrine insufficiency(One year after the operation)
  • Correlation between anastomosis non-permeability and exocrine insufficiency.(One year after the operation)
  • Evaluation of a questionnaire for pancreas exocrine insufficiency(One year after the operation)
  • Evaluation of the MRI value to determine a recurrence in the follow-up of patients after PD(One year after the operation)

研究者

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas DEMARTINES

Professor

University of Lausanne Hospitals

研究点 (2)

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