Rationale: Patients with large hepatic cysts(>5cm) may develop symptoms due to distention of
Glisson's capsule and/or compression on other abdominal organs. Frequently reported symptoms
include abdominal pain, early satiety, nausea, and dyspnea. These symptoms can be captured in
the disease-specific Polycystic Liver Disease Questionnaire (PLD-Q), a validated instrument.
The treatment of symptomatic liver cysts is aimed to improve symptoms and quality of life by
reducing cyst volume. There are two procedures available to treat symptomatic liver cysts:
percutaneous aspiration sclerotherapy and laparoscopic fenestration.
In aspiration sclerotherapy, fluid is evacuated from the liver cyst and subsequently the cyst
lining is exposed to a sclerosing agent for a limited period of time. Sclerotherapy causes
temporary recurrence of cyst fluid after drainage, but subsequently results in a steady
decrease of cyst volume in the majority of patients.
In laparoscopic fenestration the liver is exposed through laparoscopic surgery. In this
procedure the cyst is punctured and drained followed by resection of extra-hepatic cyst wall.
The safety and efficacy of aspiration sclerotherapy and laparoscopic fenestration have been
explored in two recent systematic reviews. No evident conclusion could be drawn because of
the retrospective study design in the vast majority of the studies and the heterogeneity
among these. A randomized controlled trial is warranted to identify the possible differences
in safety and efficacy in aspiration sclerotherapy and laparoscopic fenestration.
Hypothesis: The investigators expect patients treated with laparoscopic fenestration to have
better clinical outcome; i.e. a lower PLD-Q score, compared to aspiration sclerotherapy, when
measured 4 weeks after the procedure. The investigators expect this difference to become
smaller over time (after 6 and 12 months), with loss of statistical significance.
Objective: The main objective is to compare laparoscopic fenestration and aspiration
sclerotherapy in patients with large symptomatic hepatic cysts on patient-reported outcomes.
This information can be used to assess cost-effectiveness in both treatments.
Study design: A prospective, randomized clinical superiority trial in which patients will be
randomized 1:1 to one of the treatment arms. Patients will be followed for 1 year.
Study population: All patients ≥18 years who are diagnosed with a dominant, simple hepatic
cyst (>5 cm in diameter), that are symptomatic (PLD-Q score ≥20) and have an indication for
treatment (both aspiration sclerotherapy and laparoscopic fenestration) are suitable for
inclusion in this study. Only patients that are eligible for both treatments can be included
in this study. In particular, patients with multiple cysts (>20 cysts of >1.5 cm) will be
excluded as surgery leads to more complications in these patients.
Intervention: Patients will be randomly allocated to either aspiration sclerotherapy or
laparoscopic fenestration. Both procedures are performed according to the standard Radboudumc
protocols. Aspiration sclerotherapy consists of ultrasound-guided, percutaneous drainage of
the cyst with subsequent sclerosation with ethanol. Laparoscopic fenestration consists of
standard abdominal laparoscopy in which the large cyst(s) are drained and deroofed.
Main study parameters: The main study parameter is the PLD-Q score at 4 weeks after
treatment. 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.