Assessment of Treatment with Laparoscopic fenestration or Aspiration Sclerotherapy for large symptomatic hepatic cysts (ATLAS): a randomized clinical trial.
- Conditions
- Polycystic liver disease, autosomal dominant polycystic kidney disease, autosomal dominant polycystic liver disease, liver cysts
- Registration Number
- NL-OMON20962
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
•Age =18 years
•Hepatic cyst characteristics:
oLarge (>5 cm),
oSymptomatic (PLD-Q score =20),
oNon-parasitic on imaging (US/CT/MRI)
oNon-neoplastic on imaging (US/CT/MRI)
•Providing informed consent
•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 < 30 ml/min/1,73 m2)
•Coagulopathy (spontaneous INR >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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study parameter is the PLD-Q score at 4 weeks after treatment.
- Secondary Outcome Measures
Name Time Method 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.