Cystic livers Polycystic liver disease
Conditions
Interventions
At the start of the study, patients will be randomized between direct start of
treatment, and delayed start (after 1.5 years). Leuprorelin is a GnRH analogue
that stimulates the pituitary to produce
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Female patients with PLD - Age 18 to 45 years - Very large height adjusted liver volume for age: 18-30 yr >2.0 L/m; 30-35 yr >2.2 L/m, 35-40 yr > 2.5 L/m and >40 years >3.0 L/m - Confirmed ongoing liver growth - Since somatostatin analogues are proven efficacious therapy for PLD at this time it is required that patients use a somatostatin analogue and still have liver growth (as mentioned above) or the patient has a specific reason not to use this medication (e.g. patient used a somatostatin analogue in the past, but had to stop it due to inefficacy or because they did not tolerate it, or they have a contra-indication for using somatostatin analogues) - Availability of at least 1 historical MRI or CT scan made between 5 to 1 years before baseline visit
Exclusion criteria
Exclusion criteria: - Post-menopausal status or (vasomotor) symptoms indicating upcoming menopause; - AMH measurement at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the livergrowth, in percent per year, calculated from BL till t=1.5 years, compared between the direct start groep (receiving leuproreline treatment in this period) and the delayed start group (serving as a control group). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in PLD-related complaints, measured by the score on the validate PLD-questionnaire, comparing the change in PLD-Q score in the first 1.5 years between the direct start group and the delayed start group. c Exploratory outcomes: - height adjusted liver volume, compared between the direct and delayed start groep after 1.5 years - estrogen levels, compared at BL, 3 months after start treatment, 1.5 years, 21 months and 3 years - acute effects of the treatment, using the MRI or CT scans 6 months after start of treatment - safety and toleratability, incidence of (serious) adverse events, bone-density measured using DEXA-scans, drop-out rate - Quality of life, assessed by het SF-36 and BD-II - menopause related complaints, assessed by the MENQOL-questionnaire In patients with polycystic kidney disease - growth rate of kidney volume in the first 1.5 years, compared between the direct start group and delayed start group - growth rate of kidney volumes, compared within individuals, before start of treatment and during treatment - acute effects of the treatment, using the MRI or CT scans 6 months after start of treatment - change in renal function in the first 1.5 years between direct and delayed start group | — |
Countries
Netherlands
Outcome results
None listed