Aspiration sclerotherapy combined with pasireotide to improve reduction of large symptomatic hepatic cysts (SCLEROCYST): study protocol for a randomized controlled trial

What Was Tested

Researchers studied Somatostatin and Pasireotide in this randomized controlled trial publication.

This trial is registered with ClinicalTrials.gov (identifier: NCT02048319 ; registered on 6 January 2014) and EudraCT (identifier: 2013-003168-29; registered on 16 August 2013).

Who Took Part

According to the abstract, 34 participants were involved.

This single center, randomized, double-blind, placebo-controlled clinical trial evaluates the additional effect of pasireotide when combined with aspiration sclerotherapy in patients with a large (>5 cm) symptomatic hepatic cyst.

A total of 34 participants will be randomized in a 1:1 ratio.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

Random assignment meant chance, not the researchers, decided who got Somatostatin and who got the comparison, which limits bias.

As a double-blind Somatostatin study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Somatostatin could be set against what happens without it.

Patients in the control arm will receive placebo injections at corresponding intervals.

Furthermore, safety and tolerability of the combination of pasireotide and aspiration sclerotherapy will be evaluated.

What Was Measured

PubMed files the paper under topics including Clinical Protocols, Combined Modality Therapy, Cysts, Liver Diseases, Netherlands, Recurrence and Remission Induction.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Somatostatin and Pasireotide in 34 participants.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 2 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2015 (Trials), a journal based in England.

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