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Somatostatin as Inflow Modulator in Liver-transplant Recipients With Severe Portal Hypertension

A Randomized Trial

Troisi, Roberto Ivan, MSc, MD, PhD, FEBS*,†; Vanlander, Aude, MD, FEBS*; Giglio, Mariano Cesare, MD; Van Limmen, Jurgen, MD; Scudeller, Luigia, PhD§; Heyse, Bjorn, MD, PhD; De Baerdemaeker, Luc, MD, PhD; Croo, Alexander, MD*; Voet, Dirk, MD, PhD; Praet, Marleen, MD, PhD||; Hoorens, Anne, MD, PhD||; Antoniali, Giulia, PhD**; Codarin, Erika, PhD**; Tell, Gianluca, PhD**; Reynaert, Hendrik, MD, PhD††; Colle, Isabelle, MD, PhD‡‡; Sainz-Barriga, Mauricio, MD, PhD*,§§,¶¶

doi: 10.1097/SLA.0000000000003062
RANDOMIZED CONTROLLED TRIALS
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Objective: To investigate the safety and efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing liver transplantation (LT) (ClinicalTrials.gov number,01290172).

Background: In LT, portal hyperperfusion can severely impair graft function and survival, mainly in cases of partial LT.

Methods: Thirty-three patients undergoing LT for ESLD and CSPH were randomized double-blindly to receive somatostatin or placebo (2:1). The study drug was administered intraoperatively as 5-mL bolus (somatostatin: 500 μg), followed by a 2.5 mL/h infusion (somatostatin: 250 μg/h) for 5 days. Hepatic and systemic hemodynamics were measured, along with liver function tests and clinical outcomes. The ischemia-reperfusion injury (IRI) was analyzed through histological and protein expression analysis.

Results: Twenty-nine patients (18 receiving somatostatin, 11 placebo) were included in the final analysis. Ten patients responded to somatostatin bolus, with a significant decrease in hepatic venous portal gradient (HVPG) and portal flow of −28.3% and −29.1%, respectively. At graft reperfusion, HVPG was lower in patients receiving somatostatin (−81.7% vs −58.8%; P = 0.0084), whereas no difference was observed in the portal flow (P = 0.4185). Somatostatin infusion counteracted the decrease in arterial flow (−10% vs −45%; P = 0.0431). There was no difference between the groups in the severity of IRI, incidence of adverse events, long-term complications, graft, and patient survival.

Conclusions: Somatostatin infusion during LT in patients with CSPH is safe, reduces the HVPG, and preserves the arterial inflow to the graft. This study establishes the efficacy of somatostatin as a liver inflow modulator.

*Department of General, Hepato-Biliary and Liver Transplantation Surgery, Ghent University Hospital Medical School, C. Heymanslaan 10, Ghent, Belgium

Department of Clinical Medicine and Surgery, “Federico II” University, Naples, Italy

Department of Anaesthesiology, Ghent University Hospital Medical School, Belgium

§Clinical Epidemiology Unit, IRCCS Policlinico San Matteo Foundation, Pavia, Italy

Department of Sonography, Ghent University Hospital Medical School, Ghent, Belgium

||Department of Anatomopathology, Ghent University Hospital Medical School, Ghent, Belgium

**Department of Medicine, Laboratory of Molecular Biology and DNA repair, University of Udine, Italy

††Department of Basic Biomedical Sciences, Liver Cell Biology Laboratory, Vrije Universiteit Brussel (VUB), Belgium

‡‡Department of Internal Medicine, Ghent University Hospital Medical School, Ghent. Belgium

§§Abdominal Transplant Surgery, Department of Surgery, University Hospitals Leuven, Leuven, Belgium.

¶¶Laboratory of Abdominal Transplantation, Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.

Reprints: Roberto Ivan Troisi, MSc, MD, PhD, FEBS, Department of Clinical Medicine and Surgery, Federico II University of Naples, via Sergio Pansini 5, I-80131 Naples, Italy. E-mail: roberto.troisi@unina.it.

RIT and AV equally contributed to this manuscript.

Funding: The study was partially funded by a grant (WR/HHB/327/2010) from Eumedica, Belgium. The company was not involved in the study design, data collection, statistical analysis, and interpretation of data.

None of the authors have potential conflicts to disclose.

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