Comparative Analysis of Different Tests to Evaluate Prognosis of Patients on Liver Transplant Waiting List

Study Overview
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Brief Summary
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It is a cohort to evaluate the power of different diagnostic tests in predicting the prognosis of patients with severe liver disease. Patients with decompensated liver cirrhosis on the waiting list for liver transplantation will be evaluated with comparison of different diagnostic tests according to the MELD score (Model for End-Stage Liver Disease), MELD-Na (Model for End-Stage Liver Disease and sodium), indocyanine green clearance test, hepatic venous pressure gradient and transient elastography. All patients will be submitted to all the tests and prospectively followed for 6 months, to establish mortality and complications related to liver disease in order to define the value of each method to predict outcomes.

Official Title
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Comparative Analysis of Indocyanine Green Clearance Test, MELD Score, MELD-Na Score, Transient Elastography and Hepatic Venous Pressure Gradient to Evaluate Prognosis of Patients on Liver Transplant Waiting List

Conditions
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Cirrhosis, Liver Failure, Portal Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the study includes patients (80 patients) were male and female aged between 18 and 69 years with chronic liver disease with MELD inclusion greater than or equal to 14 to 30 Exclusion Criteria: they have been transplanted have a diagnosis of primary malignant liver (HCC) signed by imaging tests performed MELD scores greater than 30.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with advanced liver disease<br>Inclusion criteria are diagnosis of cirrhosis with portal hypertension detected by abdominal ultrasound with color Doppler flowmetry or upper digestive endoscopy. Exclusion criteria were age 18 or older, previous contrast allergy, hepatocellular carcinoma or any malignancy except basocellular carcinoma, renal failure (creatinine level >1.5 mg/dL), severe bleeding disorder (prothrombin activity test < 30% or platelets count <35,000/mcL) or decompensated cirrhosis characterized by severe ascites or grade II or higher encephalopathy. Patients with alcoholic cirrhosis should be abstinent for at least six months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Mortality within 6 months after evaluation, classifying as related or non-related to liver disease | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic liver failure and portal hypertension complications | Complications: gastroesophageal variceal bleeding worsening of hepatic encephalopathy decompensated ascites and spontaneous bacterial peritonitis hepatorenal syndrome | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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portal hypertension, elastography, Hepatic venous pressure gradient measurement