DRUG
Pasireotide LAR 60 mg
Pasireotide long acting release, intramuscular injection
Status
Completed
Phase
Phase 3
Enrollment
34
Locations
1
Results
Not posted
Publications
1
Study 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
DRUG
Pasireotide long acting release, intramuscular injection
PROCEDURE
Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation
DRUG
Saline solution, injected as placebo
Timeline
First posted
Jan 29, 2014
Study start
Dec 2013
Primary completion
Nov 2015
Study completion
Apr 2016
Results posted
Not reported
Registry updated
May 4, 2016
Outcomes
Proportional diameter change
Time frame · 4 weeks
Proportional change (%) in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.
Absolute reduction (cm) hepatic cyst
Time frame · 4 weeks
Absolute change in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy.
Proportional (%) and absolute cyst reduction (cm) after 12 weeks
Time frame · 12 weeks
Proportional (%) and absolute change in cyst diameter measured by ultrasound 12 weeks after aspiration sclerotherapy.
Proportion cyst recurrence
Time frame · 12 weeks
\> 80% of its original diameter
Symptomatic change and health-related quality of life
Time frame · 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
Safety
Time frame · 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
Time frame · 24 weeks
Long term proportional (%) and absolute change in cyst diameter measured by ultrasound 24 weeks after aspiration sclerotherapy.
Eligibility
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
Study locations
Netherlands. Showing up to 24 locations stored in the fast local snapshot.
Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology
Nijmegen, Netherlands
Publications
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