NCT06181474

Brief Summary

The goal of this observational study is to understand if there is a correlation between the evolution of MELD-Na and symptomatic burden of patients with advanced chronic liver disease. All patients with chronic liver disease will be invited to participate in the study. Patients will be followed prospectively with assessment of their MELD-Na score and symptom burden, according to the Edmonton Symptom Assessment System scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 12, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2025

Completed
Last Updated

May 4, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

December 12, 2023

Last Update Submit

May 1, 2025

Conditions

Keywords

HepatologyEnd Stage Liver DiseasePalliative Care

Outcome Measures

Primary Outcomes (1)

  • MELD ESAS

    Evaluate and correlate the evolution of MELD-Na and ESAS on advanced chronic liver disease.

    1 year

Interventions

ESASOTHER

Observation of symptoms

Eligibility Criteria

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

All patients with chronic liver disease followed in the Matosinhos Local Health Unit after their first episode of decompensation or are diagnosed with hepatocellular carcinoma in stage C or D of the Barcelona Liver Clinic Cancer will be invited to participate in the study.

You may qualify if:

  • All patients with chronic liver disease

You may not qualify if:

  • do not sign consent to participate
  • patients under 18 years of age
  • patients who present a recurrent degree of encephalopathy, according to the West-Haven scale, equal or greater than 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hugo Miguel Oliveira

Matosinhos Municipality, Portugal

Location

Related Publications (1)

  • Oliveira HM, Ribeiro F, Lopes G, Frias E, Andrade F, Guiomar V, Eiras E, Rego F, Nunes R. Symptom burden in end-stage liver disease: a prospective cohort study of the symptoms experienced by patients and the role of palliative care. Therap Adv Gastroenterol. 2025 Jul 13;18:17562848251353624. doi: 10.1177/17562848251353624. eCollection 2025.

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 26, 2023

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

January 25, 2025

Last Updated

May 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations