Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT05500157
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Hepatic cyst characteristics:
* Large (\>5 cm),
* Symptomatic (PLD-Q score ≥20),
* Non-parasitic on imaging (US/CT/MRI)
* Non-neoplastic on imaging (US/CT/MRI)
* Providing informed consent
Exclusion Criteria:
* Clinical indication 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 75 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05500157
Study Brief:
Protocol Section:
NCT05500157