Hepatic cyst, solitary or dominant
Conditions
Interventions
Trade Name: Signifor
Product Name: Pasireotide LAR
Pharmaceutical Form: Powder for suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the pl
Sponsors
Radboud University Nijmegen Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Population: All patients who are diagnosed with a dominant liver cyst with an indication for aspiration and sclerotherapy are suitable for inclusion in this study. Inclusion criteria: 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
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 2 or platelets 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 >8% 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. Treatment with other experimental (i.e. non marketed) therapies, within 1 month prior to dosing 18. 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 |
|---|---|
| Main Objective: The main objective is to minimize fluid reaccumulation in the hepatic cyst after aspiration sclerotherapy in order to reduce cyst size. ;Secondary Objective: The secondary objectives are to reduce symptoms, improve health-related quality of life, and recude liver cyst recurrence to prevent re-interventions.;Primary end point(s): The primary endpoint will be the proportional change (%) in cyst diameter as measured by ultrasound at the baseline visit versus the diameter obtained at 4 weeks after aspiration sclerotherapy.;Timepoint(s) of evaluation of this end point: 4 weeks after aspiration sclerotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: See secondary end points for timepoints;Secondary end point(s): Liver end points: 1. The absolute cyst reduction in centimeters as measured by ultrasound at the baseline visit versus 4 weeks after aspiration sclerotherapy. 2. The proportional change and absolute cyst reduction as measured by ultrasound at the baseline visit versus 12 weeks after aspiration sclerotherapy. 3. The proportion (%) of patients having cyst recurrence (> 80% of its original diameter) as measured by ultrasound 12 weeks after aspiration sclerotherapy. Patient reported outcome measures: 4. Change of symptoms using a PLD-related symptoms questionnaire, assessed at the baseline visit versus the value obtained at 4 and 12 weeks after aspiration sclerotherapy. 5. Change of health-related quality of live using the MOS SF-36 questionnaire, assessed at the baseline visit versus the value obtained at 4 and 12 weeks after aspiration sclerotherapy. Complications or adverse events 6. Any complications or adverse events during procedure or follow-up. | — |
Countries
Netherlands
Contacts
Public ContactWijnands, TFM
Radboud University Nijmegen Medical Center
Outcome results
None listed