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| ID | Type | Description | Link |
|---|---|---|---|
| CAAE 06343212.8.0000.5257 | Registry Identifier | Plataforma Brasil CEP/CONEP |
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| Name | Class |
|---|---|
| Rio de Janeiro State Research Supporting Foundation (FAPERJ) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with advanced liver disease | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Mortality within 6 months after evaluation, classifying as related or non-related to liver disease | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic liver failure and portal hypertension complications | Complications:
| 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Cirrhotic patients on the liver transplantation waiting list of a single center.
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| Name | Affiliation | Role |
|---|---|---|
| Guilherme FM Rezende, MD PhD | Universidade Federal do Rio de Janeiro | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário Clementino Fraga Filho / Federal University of Rio de Janeiro | Rio de Janeiro | Rio de Janeiro | 21941-913 | Brazil |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D017093 | Liver Failure |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
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| D004066 | Digestive System Diseases |