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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03714542
Enrollment
50
Registered
2018-10-22
Start date
2016-07-31
Completion date
2020-06-30
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Adenocarcinomas

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.

Interventions

OTHERPre- and postoperative MRI

Sponsors

University of Lausanne Hospitals
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the MRI precision in the delimitation of circumferential resection marginsPreoperative MRI performed up to one month before the operation date.The preoperative MRI results will be compared to the anatomopathological results.

Secondary

MeasureTime frameDescription
Determination of the pancreatic anastomosis permeabilityOne year after the operationMRI with secretin injection
Determination of the rate of exocrine insufficiencyOne year after the operationElastase test in the stool
Evaluation of the potential correlation between the tumor size and the resection margins.Preoperative MRI performed up to one month before the operation date.The preoperative MRI results will be compared to the anatomopathological results. Tumor size and resection margins will be measured in cm.
Evaluation of a questionnaire for pancreas exocrine insufficiencyOne year after the operation
Evaluation of the MRI value to determine a recurrence in the follow-up of patients after PDOne year after the operationComparison to the CT-scan
Correlation between anastomosis non-permeability and exocrine insufficiency.One year after the operationAnastomosis 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026