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

L

Lausanne University Hospital (CHUV)

Status

Completed

Conditions

Pancreas Adenocarcinomas

Treatments

Other: Pre- and postoperative MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT03714542
2016-00108

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Pre- and postoperative MRI
Other group
Description:
All patients will undergo a preoperative MRI and will have a postoperative follow-up with CT and MRI.
Treatment:
Other: Pre- and postoperative MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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