Somatostatin in Living Donor Liver Transplantation

What Was Tested

In this phase 4 trial, researchers set out to test Somatostatin.

It had two arms (groups): Somatostatin (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

In liver transplantation (LT) portal hyperperfusion can severely impair graft function and survival, mainly in cases of partial LT.

Fifty-six patients undergoing A2ALDLT for ESLD and CSPH will be randomized double-blindly to receive somatostatin or placebo (1:1).

The ischemia-reperfusion injury (IRI) will be analysed through histological and protein expression analysis.

Who Took Part

56 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients (\> 18 years old) undergoing Adult-to-Adult Living donor Liver Transplantation (LDLT) (right or left lobe). Indication for LDLT: End Stage Liver Disease with Portal Hypertension (HVPG ≥ 10mmHg).

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: complete portal vein thrombosis (pre-operative or intraoperative diagnosis); hepatopulmonary hypertension; adult-to-adult living donor liver transplantation for fulminant hepatic failure.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Somatostatin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Somatostatin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-12 with completion listed for 2020-08.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Portal venous flow changes (time frame: Day 0 - At the end of liver transplantation surgery, before skin closure).

It also tracked 8 secondary outcomes, for example Rate of patients requiring surgical inflow modulation, Changes in hepatic artery flow, Incidence of Small-for-size syndrome, Changes in postoperative portal venous flow, Rates of patients requiring early re-transplantation and Incidence of adverse and serious adverse events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Somatostatin in 56 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Somatostatin compound page, all human trials.