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

NCT03714542 | Completed

• 1 other identifier: 2016-00108
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Adenocarcinomas

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Pre- and postoperative MRI

OTHER

All patients will undergo a preoperative MRI and will have a postoperative follow-up with CT and MRI.

Other: Pre- and postoperative MRI

Interventions

Pre- and postoperative MRI OTHER

Pre- and postoperative MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

University of Lausanne Hospital

Lausanne, Canton of Vaud, 1010, Switzerland

Location

MeSH Terms

Interventions

Lead

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: October 22, 2018
• Study Start: July 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

CH (1)