NCT06150482

Brief Summary

Multicenter, retrospective cohort study investigating healthcare utilization in compensated and decompensated liver cirrhosis patients, including disease course and characteristics associated with healthcare utilization and, for example psychosocial factors.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Sep 2022Dec 2027

Study Start

First participant enrolled

September 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 26, 2025

Status Verified

December 1, 2024

Enrollment Period

4.3 years

First QC Date

May 23, 2023

Last Update Submit

September 25, 2025

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (4)

  • Number of liver cirrhosis related outpatient contacts before liver cirrhosis complications

    2 years before complication, death or loss to follow-up

  • Number of liver cirrhosis related radiographic imaging before liver cirrhosis complications

    2 years before complication, death or loss to follow-up

  • Number of liver cirrhosis related esophagogastroscopies before liver cirrhosis complications

    2 years before complication, death or loss to follow-up

  • Number of liver cirrhosis related elastographies before liver cirrhosis complications

    2 years before complication, death or loss to follow-up

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with liver cirrhosis

You may qualify if:

  • Patients ≥ 18 years of age
  • Liver cirrhosis, based on biopsy, fibroscan or diagnostic imaging data

You may not qualify if:

  • Known malignancy with hepatic metastasis at baseline
  • Liver transplantation at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gelre Ziekenhuizen

Apeldoorn, Gelderland, 7334 DZ, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

B. van Ruijven, MD

CONTACT

+31631239360britt.vanruijven@maastrichtuniversity.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

November 29, 2023

Study Start

September 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

September 26, 2025

Record last verified: 2024-12

Locations

NL(2)