Clinical trial NCT03714542: Prospective Evaluation of the Role of MRI in the Perioperative Management of Pancreas Adenocarcinomas
Official title: Prospective Evaluation of the Role of MRI in the Perioperative Management of Pancreas Adenocarcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Adenocarcinomas
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the MRI precision in the delimitation of circumferential resection margins
timeFrame: Preoperative MRI performed up to one month before the operation date.
Secondary outcomes:
measure: Evaluation of the potential correlation between the tumor size and the resection margins.
timeFrame: Preoperative MRI performed up to one month before the operation date.
measure: Determination of the pancreatic anastomosis permeability
timeFrame: One year after the operation
measure: Determination of the rate of exocrine insufficiency
timeFrame: One year after the operation
measure: Correlation between anastomosis non-permeability and exocrine insufficiency.
timeFrame: One year after the operation
measure: Evaluation of a questionnaire for pancreas exocrine insufficiency
timeFrame: One year after the operation
measure: Evaluation of the MRI value to determine a recurrence in the follow-up of patients after PD
timeFrame: One year after the operation
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University of Lausanne Hospital
state: Vaud
Study officials:
References: