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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Pasireotide long acting release, intramuscular injection
Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation
Saline solution, injected as placebo
Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology
Nijmegen, Netherlands
Proportional diameter change
Proportional change (%) in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.
Time frame: 4 weeks
Absolute reduction (cm) hepatic cyst
Absolute change in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.
Time frame: 4 weeks
Proportional (%) and absolute cyst reduction (cm) after 12 weeks
Proportional (%) and absolute change in cyst diameter measured by ultrasound 12 weeks after aspiration sclerotherapy.
Time frame: 12 weeks
Proportion cyst recurrence
\> 80% of its original diameter
Time frame: 12 weeks
Symptomatic change and health-related quality of life
Assessment of gastro-intestinal symptoms and health-related quality of life by the GIS- and SF-36 questionnaire respectively
Time frame: 4, 12 weeks and 24 weeks
Safety
Any complications or adverse events reported during procedure or follow-up
Time frame: At week 2, week 4, week 6, week 14 and week 26 after first Pasireotide injection
Proportional (%) and absolute cyst reduction (cm) after 24 weeks
Long term proportional (%) and absolute change in cyst diameter measured by ultrasound 24 weeks after aspiration sclerotherapy.
Time frame: 24 weeks
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