EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI (EXLIPSE)

University of Pisa

Status: Unknown

Conditions: Liver Cirrhosis; Hepatocellular Carcinoma; Liver Steatosis; Magnetic Resonance Imaging; Pancreatic Cancer

Treatments: Diagnostic Test: 7T Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04012021

13646

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

EX-VIVO SPECIMENS

Experimental group

Description:

Three groups of ex-vivo surgical specimen: Group A: native livers in transplant recipients Group B: liver grafts excluded for donation Group C: primary pancreatic cancer

Treatment:

Diagnostic Test: 7T Magnetic Resonance Imaging