Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.

A Single-center, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.

This study is a 5 day, single-center, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of Somatostatin used as inflow modulator in liver transplantation. Patient systemic and hepatic dynamics will be collected and recorded at predefined time-points. To evaluate the ischemia-reperfusion injury, it is planned to perform liver biopsies at two different time-points to compare the liver structure and proteomic variations.

Inclusion Criteria:

• Ability and willingness to provide written informed consent
• Cirrhotic patients with established clinically significant portal hypertension (CSPH) defined as an increase in hepatic venous pressure gradient >= 10 mmHg
• Recipients who are 18-70 years of age receiving a primary liver transplant from a brain dead donor or living donor
• Whole liver grafts and partial liver grafts can be included

Exclusion Criteria:

• Patients who are recipients of multiple solid organ transplants, or have previously received an organ or tissue transplant that may not be completely resolved by thrombectomy
• HIV positive patients
• Patients with known history of portal thrombosis or diagnosed at the time of transplantation that may not be completely resolved by thrombectomy.
• Patients included in the preoperative assessment without a CSPH at the time of the first intraoperative measurement of portal pressure
• Patients with low portal perfusion (=< 90 ml/min*100 g of LV) measured at the time of operation. Portal flows above this limit can be excluded in the eventuality that, after infusion, the portal perfusion falls below this limit
• Patients with porto-pulmonary hypertension
• Patients with known cardiac arrhythmias
• Recipients of cardiac-dead donors
• Fulminant hepatic failure patients