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.

Study Overview

• Status: Completed
• Conditions: Pancreas Adenocarcinomas
• Intervention / Treatment: Other: Pre- and postoperative MRI

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1010
      • University of Lausanne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pre- and postoperative MRI; All patients will undergo a preoperative MRI and will have a postoperative follow-up with CT and MRI.	Other: Pre- and postoperative MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the MRI precision in the delimitation of circumferential resection margins	The preoperative MRI results will be compared to the anatomopathological results.	Preoperative MRI performed up to one month before the operation date.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the potential correlation between the tumor size and the resection margins.	The preoperative MRI results will be compared to the anatomopathological results. Tumor size and resection margins will be measured in cm.	Preoperative MRI performed up to one month before the operation date.
Determination of the pancreatic anastomosis permeability	MRI with secretin injection	One year after the operation
Determination of the rate of exocrine insufficiency	Elastase test in the stool	One year after the operation
Correlation between anastomosis non-permeability and exocrine insufficiency.	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.	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	Comparison to the CT-scan	One year after the operation

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: 2016-00108