Clinical trial NCT06181474: MELD ESAS Evolution: Assessment of the Symptomatic Burden of Patients With Advanced Chronic Liver Disease
Official title: 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palliative Care
End Stage Liver DIsease
Keywords: Hepatology
End Stage Liver Disease
Palliative Care
Lead sponsor: Unidade Local de Saúde de Matosinhos, EPE
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: MELD ESAS
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Matosinhos
country: Portugal
facility: Hugo Miguel Oliveira
Study officials:
References: