Symptomatic Dominant Liver Cyst Clinical Trial
Official title:
Assessing Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Dominant Hepatic Cysts: a Randomized, Double-blind, Placebo-controlled Clinical Trial.
Liver cysts are fluid filled cavities located in the liver. They are present in 2-11% of the
general population, typically not causing any symptoms or complications. However, in a small
subset of patients complaints of pain, abdominal fullness and distension, dyspnea and nausea
occur.
Currently, aspiration and sclerotherapy is a treatment of choice in symptomatic patients
with a large dominant liver cyst. However, studies reported early fluid reaccumulation and
relative high recurrence rates of cyst growth after aspiration sclerotherapy ultimately
leading to re-interventions. In this respect, somatostatin analogues are promising agents
known for its volume reducing effect in patients with polycystic liver disease.
In this study the investigators want to evaluate the effect of combining aspiration
sclerotherapy with the multi-receptor binding, long-acting somatostatin analogue
Pasireotide.
The investigators hypothesize that administrating pasireotide before and after aspiration
sclerotherapy could prevent early fluid reaccumulation and thereby result in a greater
reduction of cyst diameter. Moreover, the investigators expect a lower rate of cyst
recurrence and subsequently lower need for re-interventions.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment