Symptomatic Dominant Liver Cyst
Conditions
Keywords
Liver cyst, Hepatic cyst, Symptomatic, Aspiration sclerotherapy
Brief summary
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.
Interventions
Pasireotide long acting release, intramuscular injection
PROCEDUREAspiration sclerotherapy
Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation
DRUGPlacebo
Saline solution, injected as placebo
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* All patients who are diagnosed with a dominant liver cyst with an indication for aspiration and sclerotherapy are suitable for inclusion in this study. In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Age 18 - 70 years * Indication for aspiration and sclerotherapy * Providing informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study ASPIRATION SCLEROTHERAPY RELATED
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportional diameter change | 4 weeks | Proportional change (%) in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportional (%) and absolute cyst reduction (cm) after 12 weeks | 12 weeks | Proportional (%) and absolute change in cyst diameter measured by ultrasound 12 weeks after aspiration sclerotherapy. |
| Proportion cyst recurrence | 12 weeks | \> 80% of its original diameter |
| Absolute reduction (cm) hepatic cyst | 4 weeks | Absolute change in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy. |
| Safety | At week 2, week 4, week 6, week 14 and week 26 after first Pasireotide injection | Any complications or adverse events reported during procedure or follow-up |
| Proportional (%) and absolute cyst reduction (cm) after 24 weeks | 24 weeks | Long term proportional (%) and absolute change in cyst diameter measured by ultrasound 24 weeks after aspiration sclerotherapy. |
| Symptomatic change and health-related quality of life | 4, 12 weeks and 24 weeks | Assessment of gastro-intestinal symptoms and health-related quality of life by the GIS- and SF-36 questionnaire respectively |
Countries
Netherlands
Outcome results
None listed