Prospective Evaluation of Multicenter Implementation of Remote Monitoring of Liver Cirrhosis Patients

Maastricht University Medical Center0 sites750 target enrollmentMay 1, 2026

ConditionsLiver Cirrhosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Liver Cirrhosis
Sponsor: Maastricht University Medical Center
Enrollment: 750
Primary Endpoint: Number of liver related complications
Status: Not Yet Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The goal of this longitudinal prospective study is to investigate disease course in patients with liver cirrhosis treated in hospitals that implemented a remote monitoring care pathway as part of their standard liver cirrhosis care pathway.

Participants will be asked to share their medical data and remote monitoring data. Therefore, this study does not contain an intervention.

Registry

clinicaltrials.gov

Start Date

May 1, 2026

End Date

February 1, 2042

Last Updated

7 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Maastricht University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Liver cirrhosis diagnosis, based on liver biopsy, fibroscan (elastography), radiographic imaging and/or clinical criteria according to applied guidelines at the time of inclusion
•Age 18 years or older
•Treated at Gastroenterology department

Exclusion Criteria

•Patients who have declined participation in scientific studies.

Outcomes

Primary Outcomes

Number of liver related complications

Time Frame: From enrollment to the end of follow-up at 15 years, or untill death.

Complications defined as: ascites, spontaneous bacterial peritonitis, variceal hemorrhage, hepatorenal syndrome, hepatopulmonary syndrome, hepatocellular carcinoma, liver failure, hepatic encephalopathy.

Secondary Outcomes

Number of liver related clinical admissions(From enrollment to the end of follow-up at 15 years, or untill death.)
Number of liver related emergency consultations(From enrollment to the end of follow-up at 15 years, or untill death.)
Number of outpatient department consultations(From enrollment to the end of follow-up at 15 years, or untill death.)
Liver transplantation(From enrollment to the end of follow-up at 15 years, or untill death.)
Mortality(From enrollment to the end of follow-up at 15 years.)
Number of liver related laboratory tests(From enrollment to the end of follow-up at 15 years, or untill death.)
Number of liver related radiographic images(From enrollment to the end of follow-up at 15 years, or untill death.)
Number of liver related biopsies(From enrollment to the end of follow-up at 15 years, or untill death.)
Percentage of completed modules in remote monitoring sessions(From enrollment to the end of follow-up at 15 years, or untill death.)