MELD ESAS Evolution: Assessment of the Symptomatic Burden of Patients With Advanced Chronic Liver Disease
NCT ID: NCT06181474
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
44 participants
OBSERVATIONAL
2024-01-01
2025-01-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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ESAS
Observation of symptoms
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Unidade Local de Saúde de Matosinhos, EPE
OTHER
Responsible Party
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Hugo Miguel Oliveira
Principal Investigator
Locations
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Hugo Miguel Oliveira
Matosinhos Municipality, , Portugal
Countries
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References
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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.
Other Identifiers
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ULSM_131/CES/JAS
Identifier Type: -
Identifier Source: org_study_id
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