Open label extension of the LOCKCYST trial;LOCKCYST: Long-acting lanreotide as a volume reducing treatment of polycystic livers
- Conditions
- polycystic liver disease10019654
- Registration Number
- NL-OMON31937
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
• 18 yrs-of age
• Multiple livercysts > 20 in PCLD- or ADPKD-patients
• Cooperating patient
• Is willing and able to comply with the study drug regimen and all other study requirements.
• Willingness to give written informed consent
• Use of oral anticonceptives or estrogen suppletion
• Females who are pregnant or breast-feeding
• History or other evidence of chronic pulmonary disease associated with functional limitation
• History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
• History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• Symptomatic gallstones (lanreotide decreases gall bladder volume)
• Renal failure requiring hemodialysis
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Reduction of total liver volume as determined by multidetector CT scan (MDCT).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Reduction of liver volume and individual cyst volume on MDCT. Symptom<br /><br>evaluation by validated questionnaire</p><br>