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Polycystic Liver DiseasePLDNCT04645251

Polycystic Liver Disease Registry (UK)

An observational study of Polycystic Liver Disease, run by Portsmouth Hospitals NHS Trust at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Multicentre, observational registry studying the natural course of polycystic liver disease. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Polycystic Liver Disease
How many people
500 participants
Where
2 sitesin 2 countries
Study dates
21 Jan 2021to 1 Dec 2030
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Mixture of adult patients with PKD and PLD

Who may be able to join

  • Patients with PLD with more than 10 liver cysts
  • Patients with PKD and PLD with more than 10 liver cysts

Who cannot join

  • Patients with PKD or PLD with less than 10 liver cysts

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Richard Aspinall, BSc, MBChB, PhD contact

02392286255

richard.aspinall@porthosp.nhs.uk

Benjamin Giles, BSc, MBBS contact

02392286000 ext. 3154

benjamin.giles@porthosp.nhs.uk

2 sites in 2 countries

Netherlands1 site, 1 recruiting

  • Radboud University Medical Center

    Nijmegen, 6525

    Thijs RM Barten, thijs.rm.barten@radboudumc.nl

    Joost PH Drenth, joostphdrenth@cs.com

    Recruiting

Other trials in Netherlands

United Kingdom1 site, 1 recruiting

  • Portmouth Hospitals University NHS Trust

    Portsmouth, Hampshire, PO63LY

    Benjamin Giles, benjamin.giles@porthosp.nhs.uk

    Richard Aspinall, richard.aspinall@porthosp.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

Multicentre, observational registry studying the natural course of polycystic liver disease.

Read the detailed description

The Polycystic Liver Disease (PLD) registry (UK) is the UK specific part of an international, multicentre, observational registry. The overall international PLD registry is led by Radboud University Medical Center, Nijmegan, Netherlands. Note- please direct any queries about the international registry to the team at Radboud University Medical Center.

All patients with Polycystic Kidney Disease (PKD) with PLD or patients with Isolated (without PKD) Polycystic Liver Disease are eligible for inclusion (>10 liver cysts).

Data will be collected prospectively and retrospectively including a specific validated PLD questionnaire (PLD-Q).

This registry provides us insight in patient characteristics, risk factors, symptoms, quality of life and treatment strategies in the biggest international PLD cohort so far. Results of this registry will be published and shared at national and international congresses.

Medical subject headings
Polycystic liver disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Map the natural course of PLD

    To establish the demographics, presence and severity of symptoms (quantified using the validated PLD-Q questionnaire), liver cyst characteristics on imaging (assessed using Qian's classification), biochemical marker abnormalities (including gamma-glutamyl transferase and alkaline phosphatase), rate and nature of complications, need for treatment, change in liver volume in patients with PLD. This data will be collected retrospectively and prospectively from clinical records and the PLD-Q questionnaire.

    Measured: 10 years

Secondary outcomes (5)

  1. Assess quality of life using the validated PLD questionnaire (PLD-Q)

    The PLD-Q questionnaire consists of 18 items assessing symptom frequency and severity. It gives a score (0-100) based on the patient's answers with a higher score indicating more severe, symptomatic disease with a poorer quality of life.

    Measured: 10 years

  2. Elucidate risk factors for developing a complication in PLD

    For patients that develop a complication of PLD (including jaundice, abdominal hernia, features of portal hypertension, cyst haemorrhage and cyst infection) we will look through their clinical record to establish if there any risk factors which are common to those with a complication (e.g. age, gender, medications, cyst phenotype).

    Measured: 10 years

  3. Elucidate elements that affect PLD progression

    For patients that have a worsening of their PLD (based on increasing symptoms as per the PLD-Q questionnaire, development of complications or need for treatment) we will look through their clinical records to establish if there any elements which are common to those with progressive disease (e.g. age, gender, medications).

    Measured: 10 years

  4. Compare effectiveness of different therapies

    For patients who have had or require treatment for PLD we will compare the effectiveness of that treatment based on change in symptoms (based on PLD-Q questionnaire), recurrence of symptoms, development of complications or need for further treatment.

    Measured: 10 years

  5. Determine whether rate of liver growth can be used to predict disease progression

    Liver growth rate will be determined using change in liver volume on serial radiology imaging. This will be compared against patients symptoms (measured via PLD-Q questionnaire), development of complications and need for treatment to establish whether there is a correlation in rate of liver growth and disease progression

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2020
  2. Study start21 Jan 2021
  3. Primary completion1 Dec 2030 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
500 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04645251
Sponsor's protocol ID
228220
Acronym
PLD
Status last verified
Dec 2025
First submitted
11 Nov 2020
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised participant data will be shared with research team at Radboud University Medical Center, Nijmegen, Netherlands.

Publications

  • Neijenhuis MK, Gevers TJ, Hogan MC, Kamath PS, Wijnands TF, van den Ouweland RC, Edwards ME, Sloan JA, Kievit W, Drenth JP. Development and Validation of a Disease-Specific Questionnaire to Assess Patient-Reported Symptoms in Polycystic Liver Disease. Hepatology. 2016 Jul;64(1):151-60. doi: 10.1002/hep.28545. Epub 2016 Apr 15.

    PubMed 26970415

  • van Aerts RMM, van de Laarschot LFM, Banales JM, Drenth JPH. Clinical management of polycystic liver disease. J Hepatol. 2018 Apr;68(4):827-837. doi: 10.1016/j.jhep.2017.11.024. Epub 2017 Nov 24.

    PubMed 29175241

  • Qian Q, Li A, King BF, Kamath PS, Lager DJ, Huston J 3rd, Shub C, Davila S, Somlo S, Torres VE. Clinical profile of autosomal dominant polycystic liver disease. Hepatology. 2003 Jan;37(1):164-71. doi: 10.1053/jhep.2003.50006.

    PubMed 12500201

Questions about this trial

What is this clinical trial studying?

An observational study of Polycystic Liver Disease, run by Portsmouth Hospitals NHS Trust at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Richard Aspinall, BSc, MBChB, PhD (02392286255, richard.aspinall@porthosp.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Map the natural course of PLD (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04645251, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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