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

NCT05500157 | Unknown DMC

• 1 other identifier: 2020-7134
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cyst; Polycystic Liver Disease; Autosomal Dominant Polycystic Kidney; Autosomal Dominant Polycystic Liver Disease

Keywords

polycystic liver disease; aspiration sclerotherapy; fenestration

Outcome Measures

Primary Outcomes (1)

• PLD-Q 4 weeks

  Comparison of PLD-Q scores 4 weeks after the procedure, adjusted for baseline PLD-Q score.

  4 weeks after the procedure

Secondary Outcomes (14)

• PLD-Q score 1, 6 and 12 months after intervention

  up to 12 months

• PLD-Q invididual symptoms

  up to 12 months

• SF-36 MCS

  up to 12 months

• SF 36 PCS

  up to 12 months

• EQ-5D-5L

  up to 12 months

Study Arms (2)

Aspiration sclerotherapy

ACTIVE COMPARATOR

Aspiration sclerotherapy is a percutaneous procedure that evacuates fluid from the liver cyst and subsequently exposes cyst lining to a sclerosing agent (e.g. ethanol, minocycline) for a limited period of time.

Procedure: aspiration sclerotherapy versus laparoscopic fenestration

Laparoscopic Fenestration

ACTIVE COMPARATOR

Laparoscopic fenestration exposes the liver through laparoscopic surgery. During this procedure the cyst is punctured and drained followed by resection of the extra-hepatic cyst wall

Procedure: aspiration sclerotherapy versus laparoscopic fenestration

Interventions

aspiration sclerotherapy versus laparoscopic fenestration PROCEDURE

See arm description

Aspiration sclerotherapy; Laparoscopic Fenestration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc University Medical Center

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Polycystic liver disease; Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Joost P.H. Drenth

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost P.H. Drenth

CONTACT

+31 24 3619190; joostphdrenth@cs.com

Thijs Barten

CONTACT

+31 24 8186542; thijs.rm.barten@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: August 12, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: April 5, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study data will be provided upon reasonable request with the principal investigator
• Access Criteria: Study data will be provided upon reasonable request with the principal investigator

Locations

NL (1)