Symptomatic Dominant Liver Cyst Clinical Trial
— SclerocystOfficial title:
Assessing Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Dominant Hepatic Cysts: a Randomized, Double-blind, Placebo-controlled Clinical Trial.
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.
| Status | Completed |
| Enrollment | 34 |
| Est. completion date | April 2016 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology | Nijmegen |
| Lead Sponsor | Collaborator |
|---|---|
| Radboud University |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportional diameter change | Proportional change (%) in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy. | 4 weeks | No |
| Secondary | Absolute reduction (cm) hepatic cyst | Absolute change in cyst diameter measured by ultrasound 4 weeks after aspiration sclerotherapy. | 4 weeks | No |
| Secondary | Proportional (%) and absolute cyst reduction (cm) after 12 weeks | Proportional (%) and absolute change in cyst diameter measured by ultrasound 12 weeks after aspiration sclerotherapy. | 12 weeks | No |
| Secondary | Proportion cyst recurrence | > 80% of its original diameter | 12 weeks | No |
| Secondary | Symptomatic change and health-related quality of life | Assessment of gastro-intestinal symptoms and health-related quality of life by the GIS- and SF-36 questionnaire respectively | 4, 12 weeks and 24 weeks | No |
| Secondary | Safety | Any complications or adverse events reported during procedure or follow-up | At week 2, week 4, week 6, week 14 and week 26 after first Pasireotide injection | Yes |
| Secondary | Proportional (%) and absolute cyst reduction (cm) after 24 weeks | Long term proportional (%) and absolute change in cyst diameter measured by ultrasound 24 weeks after aspiration sclerotherapy. | 24 weeks | No |