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Completed

NCT Number: NCT03714542

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lausanne Hospital

Lausanne, Canton of Vaud, 1010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Pre- and postoperative MRI

Other

Primary outcomes

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

    Time frame: Preoperative MRI performed up to one month before the operation date.

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

Secondary outcomes

  1. Evaluation of the potential correlation between the tumor size and the resection margins.

    Time frame: Preoperative MRI performed up to one month before the operation date.

    The preoperative MRI results will be compared to the anatomopathological results. Tumor size and resection margins will be measured in cm.

  2. Determination of the pancreatic anastomosis permeability

    Time frame: One year after the operation

    MRI with secretin injection

  3. Determination of the rate of exocrine insufficiency

    Time frame: One year after the operation

    Elastase test in the stool

  4. Correlation between anastomosis non-permeability and exocrine insufficiency.

    Time frame: One year after the operation

    Anastomosis non-permeability will be assessed with MRI with secretin one year after the operation. A score of permeability (number) will be appointed to determine permeability or not. Exocrine insufficiency will be defined by stool elastase measure <200 ug/g one year after the operation.

  5. Evaluation of a questionnaire for pancreas exocrine insufficiency

    Time frame: One year after the operation

  6. Evaluation of the MRI value to determine a recurrence in the follow-up of patients after PD

    Time frame: One year after the operation

    Comparison to the CT-scan

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2018
Registry last updated
Jun 11, 2020

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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