A randomized, double-blind, placebo-controlled clinical trial assessing the efficacy of combining pasireotide with aspiration sclerotherapy to improve volume reduction of dominant hepatic cysts

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 34

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
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the proportional change (%) in cyst<br /><br>diameter measured by ultrasound after 4 weeks of follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are the absolute reduction in centimetres after 4 weeks,<br /><br>the proportional and absolute reduction after 2, 12 and 24 weeks, the<br /><br>proportion of patients having cyst recurrence (i.e. > 80% of its original<br /><br>diameter) at follow-up, change of symptoms and health-related quality of life<br /><br>(HRQL) and any complications or adverse events reported during procedure or<br /><br>follow-up.</p><br>