Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Hepatic Cysts

What Was Tested

This registered phase 3 trial tested Pasireotide.

Liver cysts are fluid filled cavities located in the liver.

However, in a small subset of patients complaints of pain, abdominal fullness and distension, dyspnea and nausea occur.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

Patients in the placebo arm will receive two injections of saline solution corresponding to the scheme of the intervention group.

The registry classes the interventions as drug and procedure.

Who Took Part

34 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: All patients who are diagnosed with a dominant liver cyst with an indication for aspiration and sclerotherapy are suitable for inclusion in this study. Age 18 - 70 years. Indication for aspiration and sclerotherapy. Providing informed consent.

The full record lists 4 inclusion and 22 exclusion criteria; among the exclusions: signs of cyst bleeding on ultrasound; signs of cyst infection (elevated crp and/or leukocytes or temperature exceeding 38 degrees with the exclusion of a different focus); cyst \< 5 cm.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Pasireotide group and the comparison group should start out alike.

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

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

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

It started in 2013-12 with completion listed for 2015-11.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proportional diameter change (time frame: 4 weeks).

It also tracked 6 secondary outcomes, for example Proportion cyst recurrence, Symptomatic change and health-related quality of life and Safety.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Pasireotide in 34 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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