Transplant Trial Watch

Somatostatin as Inflow Modulator in Liver-transplant Recipients With Severe Portal Hypertension: A Randomized Trial.

Troisi RI, Vanlander A, et al.

Ann Surg. 2018; [record in progress].

To investigate the safety and efficacy of somatostatin (SST) as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing liver transplantation (LT).

Patients were randomized (2:1) to receive SST or placebo. Hepatic and systemic hemodynamics were measured, along with liver function tests and clinical outcomes. Ischemia-reperfusion injury (IRI) was analyzed through histological and protein expression analysis. Blood samples were taken daily for the first 7 postoperative days (PODs) and at POD 14. Further samples were obtained as required according to the patient’s clinical condition.

33 adult liver transplant recipients with ESLD and CSPH.

The primary endpoint was the hemodynamic response (defined as a 20% reduction of hepatic venous portal gradient (HVPG) in response to the SST bolus). Secondary endpoints included hemodynamic response, liver function tests and clinical outcomes in the short and long-term period.

Median follow-up of 55.9 months (IQR 50.4–78).

CET Conclusions
This small placebo-controlled study investigated the role of somatostatin in reducing the portal venous pressure during liver transplantation in patients with portal hypertension. Use of somatostatin resulted in a significant reduction in the hepatic venous portal gradient compared to placebo. No difference was seen in the severity of the ischaemia-reperfusion injury or in clinical outcomes. This study is interesting, but ultimately underpowered to detect any differences in meaningful clinical outcomes. It does, however, provide strong justification for a larger study of the use of somatostatin in this group, and also possibly in patients with portal hypertension undergoing liver resection. How it compares to standard surgical management of portal hypertension (e.g. shunting or splenic vein ligation) is also unclear and would need further study.

Jadad score

Data analysis
Modified intention-to-treat analysis

Allocation concealment

Trial registration - NCT01290172

Funding source
Industry & non-industry funded