Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Hepatic Cysts (Sclerocyst)

This is an interventional treatment trial for Symptomatic Dominant Liver Cyst focused on measuring Liver cyst, Hepatic cyst, Symptomatic, Aspiration sclerotherapy Read More

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 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
11. History of pancreatitis

12. Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment

    FURTHERMORE:

13. Use of oral contraception or estrogen supplementation
14. Intervention (i.e. aspiration with or without sclerotherapy or surgical intervention) within six months before baseline
15. Treatment with somatostatin analogues within six months before baseline
16. 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