Assessment of Treatment with Laparoscopic fenestration or Aspiration Sclerotherapy for large symptomatic hepatic cysts (ATLAS): a randomized clinical trial.

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: We 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. We expect this
difference to become smaller over time (after 6 and 12 months), with loss of
statistical significance.

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.

A single-center, 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.

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.

All symptomatic liver cysts patients that are included have an indication for
treatment by aspiration sclerotherapy or laparoscopic fenestration. The
described follow-up is according to the regular liver cyst treatment local
protocol, including site visits, questionnaires and ultrasound. For patients
allocated to the aspiration sclerotherapy arm of the study, one additional
CT-scan is made at 4 weeks, which would not be standard protocol. In case of an
inconclusive ultrasound at 6 months, a CT-scan (without contrast, low-dose)
will be performed to measure cyst volume.
In summary, besides random allocation and extra follow-up CT-scan(s), the study
forms no extra burden or associated risks. Associated risks in aspiration
sclerotherapy are temporary and mild, e.g. local pain. Associated risks in
laparoscopic fenestration are bile leakage, ascites, pleural effusion or
infections. The number of questionnaire-sets that need to be filled in will be
4-5 (dependent on intermittent recurrence). The number of CT-scans that will
be made during the study is 1, 2 or 3, depending on available imaging before
screening and need for a CTs.