Background: Somatostatin (SST) infusion decrease portal pressure in acute variceal bleeding in cirrhotic patients. Despite liver transplantation (LTx), recipients with portal hypertension (PHT) display different degrees of portal hyperperfusion especially after receiving segmental grafts (SG). Little data are available in clinical LTx regarding the use of SST as inflow modulator. To evaluate the safety and the pharmacological properties of SST a prospective RCT was conceived.

Methods: A RCT, placebo-controlled study (NCT 01290172, EUDRACT 2008-008318-24) was designed to allocate patients with measured PHT in a 1:2 ratio to either the placebo group (P) or the SST group (S). SST patients received a continuous infusion of 6-mg/24 hrs. during 5 days. The primary objective was to assess the safety and efficacy of SST in decreasing portal vein flow (PVF) and hepatic vein pressure gradients (HVPG=portal vein pressure – central vein pressure), eventually increasing the hepatic artery flow (HAF). A secondary objective was to investigate the SST effects on ischemia/reperfusion injury (IRI) as measured by expression levels of known stress-responsive proteins.

Results: Twelve patients were included in the P group and 21 in the S group. At a median follow up of 21 months (2-46), all patients but five (85%) were in good health with normally functioning grafts. PVF decrease (p=0.02), with a trend for higher HAF was observed (p=0.058) and HVPG decrease (p=0.016) in the S group compared to the P group was observed. Neither vascular thrombosis nor significant differences in AST and INR peaks between both groups were observed, as well as in proteomic expression.

Conclusions: Somatostatin has proven to be a safe and useful drug to consistently reduce PVF and HVPG. The trend for HAF increase could be particularly interesting in SG transplantation where its value can be decreased. Further studies must be addressed to understand its role in IRI.

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