Polycystic liver disease, autosomal dominant polycystic kidney disease, autosomal dominant polycystic liver disease, liver cysts
Conditions
Interventions
Patients will be randomly allocated to either aspiration sclerotherapy or laparoscopic fenestration. Both procedures are performed according to the standard Radboudumc protocols. Aspiration sclerother
Sponsors
Radboudumc
Eligibility
Inclusion criteria
Inclusion criteria: • Age =18 years • Hepatic cyst characteristics: o Large (>5 cm), o Symptomatic (PLD-Q score =20), o Non-parasitic on imaging (US/CT/MRI) o Non-neoplastic on imaging (US/CT/MRI) • Providing informed consent
Exclusion criteria
Exclusion criteria: • Clinical suspicion of a complicated hepatic cyst (cyst rupture or active cyst infection) • Cyst is not laparoscopically accessible for surgery • Cyst is not percutaneously (ultrasound-guided) accessible for aspiration • More than 20 cysts of >1.5 cm • Age above 70 years • ASA IV • ECOG score >1 • Aspiration sclerotherapy or laparoscopic fenestration of hepatic cysts was performed in the last 6 months. • Severe renal impairment (eGFR 2 or platelet count < 80 x 109/l) • Radiologic contrast allergy • Pregnancy • 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 (e.g. inability to fill out questionnaires).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the PLD-Q score at 4 weeks after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are among others: PLD-Q score at baseline, 6 months and 12 months; liver volume (CT) at baseline and 4 weeks; cyst volume (ultrasound) at baseline, 4 weeks, 6 months and 12 months; complications according to Clavien-Dindo; admission duration, recurrence and re-intervention rates. | — |
Contacts
Public ContactThijs Barten
Radboudumc
Outcome results
None listed