The aim of this study is to reduce polycystic liver volume by treating with octreotide, whether or not combined with everolimus; to assess whether combination therapy of everolimus and octreotide gives a bigger reduction of polycystic liver volume than octreotide monotherapy.
This is a single center randomized, open-label, parallel study comparing the safety and efficacy of everolimus-octreotide LAR treatment to monotherapy octreotide LAR in adult symptomatic patients with polycystic livers because of polycystic liver disease (PCLD). We aim to include 44 patients affected by a polycystic liver either due to PCLD, 22 patients in the combination group and 22 patients in the mono therapy group.The duration of the trial will be 52 weeks. The treatment will be 48 weeks and the last control visit will take place four weeks after the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
2.5 mg every day orally
40 mg every 28 days IM
Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Liver volume
change of total liver volume in terms of percentage from baseline to 12 months as determined by CT
Time frame: at baseline and at 12 months
Symptoms
Change in symptoms, measured by GI-questionnaire
Time frame: baseline and 12 months
Quality of Life
Change in quality of life, measured by EuroQoL-questionnaire
Time frame: baseline and 12 months
Responders
Proportion of patients having any reduction in total liver volume after 12 months
Time frame: baseline and 12 months
Adverse events
Adverse events that occur in these 12 months
Time frame: During 12 months of treatment
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