Clinical trial NCT01290172: Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.
Official title: A Single-center, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Transplant With Clinically Significant Portal Hypertension
Keywords: Liver transplant
portal hypertension
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of safety and efficacy using Somatostatin.
timeFrame: 5 days
Secondary outcomes:
measure: To elucidate pathophysiological pathways in non-cirrhotic grafted livers.
timeFrame: 35 days
measure: To evaluate the reduction of ischemia-reperfusion injury (cytoprotective effect)
timeFrame: 1 hour after reperfusion and 5 days
measure: To evaluate the efficacy of Somatostatin in the prevention of the small-for-size syndrome (SFSS) in partial liver transplantation.
timeFrame: after 35 days
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital, Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Roberto Troisi, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: