UnknownNot Applicable

Assessment of Treatment With Laparoscopic Fenestration or Aspiration Sclerotherapy for Large Symptomatic Hepatic Cysts

Netherlands70 participantsStarted 2022-10-01

Plain-language summary

Patients with large hepatic cysts (\> 5cm) may develop symptoms. These can be captured with the polycystic liver disease questionnaire (PLD-Q). Treatment of large hepatic cysts consists of aspiration sclerotherapy or laparoscopic fenestration. The safety and efficacy of both procedures has been explored in two recent systematic reviews yet no evident conclusion regarding superiority of either procedure could be drawn. The main objective of the ATLAS trial is to compare laparoscopic fenestration and aspiration sclerotherapy in patients with large symptomatic hepatic cysts on patient-reported outcomes.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PLD-Q 4 weeks

Timeframe: 4 weeks after the procedure

Trial details

NCT IDNCT05500157

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-01

Contact for this trial

Joost P.H. Drenth

+31 24 3619190 joostphdrenth@cs.com

View on ClinicalTrials.gov More Liver Cyst trials