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Somatostatin as inflow modulator in liver-transplant recipients with severe portal hypertension : a randomized trial

(2019) ANNALS OF SURGERY. 269(6). p.1025-1033
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Abstract
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 mu g), followed by a 2.5 mL/h infusion (somatostatin: 250 mu g/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.
Keywords
hepatic artery flow, hepato venous portal gradient, liver transplantation, portal flow modulation, portal pressure, somatostatin, REDOX PROTEOMICS, GRAFT SIZE, VEIN FLOW, INJURY, CIRRHOSIS, HEMODYNAMICS, PRESERVATION, OCTREOTIDE, PRESSURE, BIOPSIES

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MLA
Troisi, Roberto, et al. “Somatostatin as Inflow Modulator in Liver-Transplant Recipients with Severe Portal Hypertension : A Randomized Trial.” ANNALS OF SURGERY, vol. 269, no. 6, 2019, pp. 1025–33.
APA
Troisi, R., Vanlander, A., Giglio, M. C., Van Limmen, J., Scudeller, L., Heyse, B., … SAINZ-BARRIGA, M. (2019). Somatostatin as inflow modulator in liver-transplant recipients with severe portal hypertension : a randomized trial. ANNALS OF SURGERY, 269(6), 1025–1033.
Chicago author-date
Troisi, Roberto, Aude Vanlander, Mariano Cesare Giglio, Jurgen Van Limmen, Luigia Scudeller, Bjorn Heyse, Luc De Baerdemaeker, et al. 2019. “Somatostatin as Inflow Modulator in Liver-Transplant Recipients with Severe Portal Hypertension : A Randomized Trial.” ANNALS OF SURGERY 269 (6): 1025–33.
Chicago author-date (all authors)
Troisi, Roberto, Aude Vanlander, Mariano Cesare Giglio, Jurgen Van Limmen, Luigia Scudeller, Bjorn Heyse, Luc De Baerdemaeker, Alexander Croo, Dirk Voet, Marleen Praet, Anne Hoorens, Giulia Antoniali, Erika Codarin, Gianluca Tell, Hendrik Reynaert, Isabelle Colle, and MAURICIO SAINZ-BARRIGA. 2019. “Somatostatin as Inflow Modulator in Liver-Transplant Recipients with Severe Portal Hypertension : A Randomized Trial.” ANNALS OF SURGERY 269 (6): 1025–1033.
Vancouver
1.
Troisi R, Vanlander A, Giglio MC, Van Limmen J, Scudeller L, Heyse B, et al. Somatostatin as inflow modulator in liver-transplant recipients with severe portal hypertension : a randomized trial. ANNALS OF SURGERY. 2019;269(6):1025–33.
IEEE
[1]
R. Troisi et al., “Somatostatin as inflow modulator in liver-transplant recipients with severe portal hypertension : a randomized trial,” ANNALS OF SURGERY, vol. 269, no. 6, pp. 1025–1033, 2019.
@article{8592363,
  abstract     = {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 mu g), followed by a 2.5 mL/h infusion (somatostatin: 250 mu g/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.},
  author       = {Troisi, Roberto and Vanlander, Aude and Giglio, Mariano Cesare and Van Limmen, Jurgen and Scudeller, Luigia and Heyse, Bjorn and De Baerdemaeker, Luc and Croo, Alexander and Voet, Dirk and Praet, Marleen and Hoorens, Anne and Antoniali, Giulia and Codarin, Erika and Tell, Gianluca and Reynaert, Hendrik and Colle, Isabelle and SAINZ-BARRIGA, MAURICIO},
  issn         = {0003-4932},
  journal      = {ANNALS OF SURGERY},
  keywords     = {hepatic artery flow,hepato venous portal gradient,liver transplantation,portal flow modulation,portal pressure,somatostatin,REDOX PROTEOMICS,GRAFT SIZE,VEIN FLOW,INJURY,CIRRHOSIS,HEMODYNAMICS,PRESERVATION,OCTREOTIDE,PRESSURE,BIOPSIES},
  language     = {eng},
  number       = {6},
  pages        = {1025--1033},
  title        = {Somatostatin as inflow modulator in liver-transplant recipients with severe portal hypertension : a randomized trial},
  url          = {http://dx.doi.org/10.1097/sla.0000000000003062},
  volume       = {269},
  year         = {2019},
}

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