Clinical trial NCT04012021: EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI
Official title: EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI - The EXLIPSE Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Liver Steatosis
Hepatocellular Carcinoma
Pancreatic Cancer
Magnetic Resonance Imaging
Keywords: liver
cirrhosis
steatosis
hepatocellular carcinoma
pancreatic cancer
7 tesla
magnetic resonance imaging
Lead sponsor: University of Pisa
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero, Universitaria Pisana
name: Imago 7
First posted: 2019-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Three single groups to be included
Primary purpose: BASIC_SCIENCE

Brief summary: Aim of this study is to evaluate the correlation between the characteristics detected by the 7T MRI equipment and the histological composition of native explanted livers (group A), liver graft excluded for donation (group B) and surgical specimens of primary pancreatic tumour, which underwent pancreaticoduodenectomy (group C).


Eligibility criteria: GROUP A of Native Liver

Inclusion Criteria:

* informed consent
* full possession of one's faculties
* patients who are going to undergo liver transplantation, independently from previous therapy or from the primary disease they are affected by.

Exclusion Criteria:

* patients affected by polycystic liver disease
* excluded from liver transplantation.

GROUP B of Excluded Grafts

Inclusion Criteria:

- liver grafts with histologically proven macrovescic steatosis, not fit for transplantation

Exclusion Criteria:

* liver grafts histologically proven macrovescic steatosis fit for transplantation
* liver grafts not fit for transplantation due to causes other than steatosis

GROUP C of Focal Pancreatic Lesion

Inclusion Criteria:

* informed consent
* full possession of one's faculties
* pancreatic lesion assessed by CT examination and histologically proved, which are candidates for pancreaticoduodenectomy or total pancreatectomy

Exclusion Criteria:

- excluded from surgery due to the severity of their condition.

Primary outcomes:
measure: Evaluate the correlation between the characteristics detected by the MRI equipment and the histological composition of ex-vivo specimens from hepatic and pancreatic tissues and lesions
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
state: PI
Study officials:
affiliation: University of Pisa
name: Laura Crocetti, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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