Portal Hypertension Clinical Trial
Official title:
Somatostatin as Inflow Modulator in Adult-to-adult Living Donor Liver Transplantation: a Randomized, Double-blind, Placebo-controlled Trial
Aim of the study is to investigate the safety and the efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing Adult-to-Adult living donor liver transplantation (A2ALDLT).
In liver transplantation (LT) portal hyperperfusion can severely impair graft function and
survival, mainly in cases of partial LT. Perioperative somatostatin infusion has been shown
to be safe, to reduce the Hepatic Vein to Portal Vein Gradients and to preserve the arterial
inflow to the graft in whole liver transplantation. In partial grafts, the pharmacological
action of somatostatin could reduce the graft damage due to portal hyperperfusion and
arterial hypoperfusion, reducing the incidence of small-for-size syndrome and graft loss and
improving the patients survival.
Objective of the study is to investigate the safety and the efficacy of somatostatin as liver
inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant
portal hypertension (CSPH) undergoing Adult-to-Adult living donor liver transplantation
(A2ALDLT).
Fifty-six patients undergoing A2ALDLT for ESLD and CSPH will be randomized double-blindly to
receive somatostatin or placebo (1:1). The study drug will be administered intraoperatively
as 5ml bolus (somatostatin: 500 μg), followed by a 2.5 ml/hour infusion (somatostatin: 250
μg/hour) for 10 days. Hepatic and systemic hemodynamic will be measured, along with liver
function tests and clinical outcomes. The ischemia-reperfusion injury (IRI) will be analysed
through histological and protein expression analysis.
The primary endpoint of the study will be the portal vein flow reduction measured at the end
of liver transplant. Secondary end-points will be the reduction in the portal vein pressure,
the rate of patients requiring surgical inflow modulation, the incidence of small for size
syndrome, the severity of the ischemia reperfusion injury, the need for early
re-transplantation (6 months), the incidence of adverse and serious adverse events, the
90-day mortality.
This randomized controlled trial could be the first to show the efficacy of somatostatin as
modulator of the graft inflow in living-donor liver transplantation and potential improvement
in graft and patient survival.
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