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

Phase 3

Withdrawn

Conditions: hepatic cysts
10019806
10019654
10019818

Registration Number: NL-OMON51055

Lead Sponsor: niversitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 70

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

• 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 10^9/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
<p>Main study parameters: The main study parameter is the PLD-Q score at 4 weeks<br /><br>after treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are among others: PLD-Q score at baseline, 6 months and 12<br /><br>months; liver volume (CT) at baseline and 4 weeks; cyst volume (ultrasound) at<br /><br>baseline, 4 weeks, 6 months and 12 months; complications according to<br /><br>Clavien-Dindo; admission duration, recurrence and re-intervention rates. </p><br>