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

Primary Purpose

Pancreas Adenocarcinomas

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Pre- and postoperative MRI
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreas Adenocarcinomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Lausanne Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pre- and postoperative MRI

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of the MRI precision in the delimitation of circumferential resection margins
The preoperative MRI results will be compared to the anatomopathological results.

Secondary Outcome Measures

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.
Determination of the pancreatic anastomosis permeability
MRI with secretin injection
Determination of the rate of exocrine insufficiency
Elastase test in the stool
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.
Evaluation of a questionnaire for pancreas exocrine insufficiency
Evaluation of the MRI value to determine a recurrence in the follow-up of patients after PD
Comparison to the CT-scan

Full Information

First Posted
August 5, 2016
Last Updated
June 10, 2020
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03714542
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Adenocarcinomas

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre- and postoperative MRI
Arm Type
Other
Arm Description
All patients will undergo a preoperative MRI and will have a postoperative follow-up with CT and MRI.
Intervention Type
Other
Intervention Name(s)
Pre- and postoperative MRI
Primary Outcome Measure Information:
Title
Evaluation of the MRI precision in the delimitation of circumferential resection margins
Description
The preoperative MRI results will be compared to the anatomopathological results.
Time Frame
Preoperative MRI performed up to one month before the operation date.
Secondary Outcome Measure Information:
Title
Evaluation of the potential correlation between the tumor size and the resection margins.
Description
The preoperative MRI results will be compared to the anatomopathological results. Tumor size and resection margins will be measured in cm.
Time Frame
Preoperative MRI performed up to one month before the operation date.
Title
Determination of the pancreatic anastomosis permeability
Description
MRI with secretin injection
Time Frame
One year after the operation
Title
Determination of the rate of exocrine insufficiency
Description
Elastase test in the stool
Time Frame
One year after the operation
Title
Correlation between anastomosis non-permeability and exocrine insufficiency.
Description
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.
Time Frame
One year after the operation
Title
Evaluation of a questionnaire for pancreas exocrine insufficiency
Time Frame
One year after the operation
Title
Evaluation of the MRI value to determine a recurrence in the follow-up of patients after PD
Description
Comparison to the CT-scan
Time Frame
One year after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Lausanne Hospital
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1010
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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