The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy

What Was Tested

In this phase 3 trial, researchers set out to test Terlipressin.

In this multicenter randomized controlled study, the researchers aim to evaluate the effects of terlipressin in the patients who underwent liver resection complicated by portal vein hypertension.

It had two arms (groups): Terlipressin plus standard care (experimental) and Standard care (other).

Participants were not administrated with terlipressin during surgery and were routinely managed after surgery.

The registry classes the interventions as drug and other.

More on the Plan

The primary outcome is the total abdominal drain on postoperative day (POD) 1 to 3.

The secondary outcomes are: (1) the incidence of post-hepatectomy liver failure; (2) post-operative acute kidney injury; (3) the side effects of terlipressin.

Who Took Part

86 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Subjects signed informed consent. An open liver resection is planned. Hepatitis B virus infection background. Pre-operative liver function is Child-Pugh A. Portal vein pressure \> 12 mmHg at 5 min after liver resection.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: age \< 18 y or \> 75 y; subjects received anti-cancer therapy within 3 months before surgery, or with a history of open or laparoscopic surgery; portal vein tumor thrombus was confirmed by preoperative imaging study.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

The Terlipressin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Terlipressin study: the participants and staff both knew the treatment.

It started in 2019-11-07 with completion listed for 2020-12-30.

It ran at 4 sites in China (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The total abdominal drainage (time frame: From post-operative day 1 to day 4).

It also tracked 3 secondary outcomes, for example The incidence of post-hepatectomy liver failure, The incidence of acute kidney injury and The side effects of terlipressin.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Terlipressin in 86 people.

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

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