An interventional study of Pre- and postoperative MRI in Pancreas Adenocarcinomas, sponsored by University of Lausanne Hospitals. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by University of Lausanne Hospitals · Not applicable, Interventional, and Diagnostic
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 50 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
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Exclusion Criteria:
All patients will undergo a preoperative MRI and will have a postoperative follow-up with CT and MRI.
Other: Pre- and postoperative MRI
Evaluation of the MRI precision in the delimitation of circumferential resection margins
The preoperative MRI results will be compared to the anatomopathological results.
Time frame: Preoperative MRI performed up to one month before the operation date.
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.
Time frame: Preoperative MRI performed up to one month before the operation date.
Determination of the pancreatic anastomosis permeability
MRI with secretin injection
Time frame: One year after the operation
Determination of the rate of exocrine insufficiency
Elastase test in the stool
Time frame: 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.
Time frame: One year after the operation
Evaluation of a questionnaire for pancreas exocrine insufficiency
Time frame: 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
Time frame: One year after the operation
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University of Lausanne Hospitals