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Clinical Trials/NCT06181474
NCT06181474CompletedNot Applicable

Assessment of the Symptomatic Burden of Patients With Advanced Chronic Liver Disease. Correlation Between the Model for End-Stage Liver Disease (MELD)-Na and the Edmonton Symptom Assessment System Scale (ESAS).

Unidade Local de Saúde de Matosinhos, EPE1 site in 1 country44 target enrollmentStarted: January 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
44
Locations
1
Primary Endpoint
MELD ESAS

Study Overview

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.

Detailed Description

  1. Methodology - Prospective observational study
  2. 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.

All patients who do not sign consent to participate, patients under 18 years of age and patients who present a recurrent degree of encephalopathy, according to the West-Haven scale, equal or greater than 2, will be excluded. 3. Sample - Non-probabilistic for convenience 4. Data collection instrument - Patients will be followed prospectively with quarterly assessment, or after each episode of decompensation, of their MELD-Na score and symptom burden, according to the Edmonton Symptom Assessment System scale (ESAS), with introduction of 3 other symptoms prevalent in patients with chronic liver disease: sexual dysfunction sexual, cramps and pruritus. The minimum analysis for each patient will be 2 assessments.

All symptoms greater than 5 points will be considered moderate to severe and formal referral to the palliative care team will be discussed with the patient and their attending physician. Subsequently evaluating its effectiveness in symptomatic control. 5. Aims - This observational study will try to understand if there is a correlation between the evolution of MELD-Na and symptomatic burden of patients with advanced chronic liver disease. As well as the influence that the implementation of palliative care have on symptom burden of advanced chronic liver disease patients.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All patients with chronic liver disease

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

MELD ESAS

Time Frame: 1 year

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Unidade Local de Saúde de Matosinhos, EPE
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hugo Miguel Oliveira

Principal Investigator

Universidade do Porto

Study Sites (1)

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