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

Phase 1

Completed

• Conditions: Liver Transplant With Clinically Significant Portal Hypertension
• Interventions: Drug: Administration of Somatostatin; Drug: Administration of placebo

• Registration Number: NCT01290172
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-27
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Somatostatin	Administration of Somatostatin	Patients in this group receive treatment with Somatostatin for 5 days.
Placebo	Administration of placebo	Patients in this group receive a placebo for 5 days.

Primary Outcome Measures

Name	Time	Method
Evaluation of safety and efficacy using Somatostatin.	5 days	To evaluate the safety and efficacy, using Somatostatin as portal vein flow and pressure modulator in liver transplantation in humans. Hepatic and systemic hemodynamic measurements will be recorded prior, during and after the bolus infusion of Somatostatin/Placebo during liver transplantation. Infusion of Somatostatin/Placebo will be continued for 5 days.

Secondary Outcome Measures

Name	Time	Method
To elucidate pathophysiological pathways in non-cirrhotic grafted livers.	35 days
To evaluate the reduction of ischemia-reperfusion injury (cytoprotective effect)	1 hour after reperfusion and 5 days
To evaluate the efficacy of Somatostatin in the prevention of the small-for-size syndrome (SFSS) in partial liver transplantation.	after 35 days

Trial Locations

Locations (1)

University Hospital, Ghent; 🇧🇪 Ghent, Belgium