dominant or simple liver cyst Hepatic cyst liver cyst
Conditions
Interventions
The subjects will be randomized (1:1) into two groups. Both groups will undergo
aspiration sclerotherapy following the standard procedure. The intervention
group will additionally receive two inject
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study;ASPIRATION SCLEROTHERAPY RELATED EXCLUSION CRITERIA 1. Signs of cyst bleeding on ultrasound 2. Signs of cyst infection (elevated CRP and/or leukocytes or temperature exceeding 38 degrees with the exclusion of a different focus) 3. Cyst < 5 cm 4. Coagulopathy (INR > 2 or platelets < 80 x 10^9) 5. Severe co-morbidity contraindicating anesthesia (i.e. ASA 4 classification);SOMATOSTATIN TREATMENT RELATED EXCLUSION CRITERIA 6. Patients with a known hypersensitivity to SST analogues or any component of the pasireotide LAR or SQ formulations 7. Pregnant or nursing women 8. Symptomatic cholecystolithiasis 9. QT interval related exclusion criteria 9.1 Known (congenital) long QT syndrome or QTcF at screening 470 msec 9.2 Family history of long QT syndrome or idiopathic sudden death 9.3 Uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure, unstable angina or sustained and/or clinically significant cardiac arrhythmias (e.g. bradycardia) 9.4 Risk factors for torsades de pointes: hypokalemia, hypomagnesemia, hypocalcaemia, cardiac failure, clinically significant/symptomatic bradycardia, or high grade AV block 9.5 Patients with concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure 9.6 Taking anti-arrhythmic medicinal products or other substances that are known to lead to QT prolongation 10. Uncontrolled diabetes as defined by HbA1C > 64 mmol/ml despite adequate therapy 12. History of pancreatitis 13. Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment;FURTHERMORE 14. Use of oral contraception or estrogen supplementation 15. Intervention (i.e. aspiration with or without sclerotherapy or surgical intervention) within six months before baseline 16. Treatment with somatostatin analogues within six months before baseline 17. Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the proportional change (%) in cyst diameter measured by ultrasound after 4 weeks of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the absolute reduction in centimetres after 4 weeks, the proportional and absolute reduction after 2, 12 and 24 weeks, the proportion of patients having cyst recurrence (i.e. > 80% of its original diameter) at follow-up, change of symptoms and health-related quality of life (HRQL) and any complications or adverse events reported during procedure or follow-up. | — |
Countries
Netherlands
Outcome results
None listed