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NCT Number: NCT04645251

Polycystic Liver Disease Registry (UK)

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

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Key information

Conditions

Polycystic Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Medical Center, Nijmegen, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Map the natural course of PLD

    Time frame: 10 years

    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.

Secondary outcomes

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

    Time frame: 10 years

    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.

  2. Elucidate risk factors for developing a complication in PLD

    Time frame: 10 years

    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).

  3. Elucidate elements that affect PLD progression

    Time frame: 10 years

    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).

  4. Compare effectiveness of different therapies

    Time frame: 10 years

    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.

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

    Time frame: 10 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Giles, BSc, MBBS

CONTACT

[email protected]

02392286000 ext. 3154

Richard Aspinall, BSc, MBChB, PhD

CONTACT

[email protected]

02392286255

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Collaborators

  • Radboud University Medical Center

Registry information

Acronym: PLD

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Nov 27, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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