Comparative Analysis of Different Tests to Evaluate Prognosis of Patients on Liver Transplant Waiting List
NCT ID: NCT01774617
Last Updated: 2020-10-09
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
80 participants
OBSERVATIONAL
2015-12-31
2018-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* have a diagnosis of primary malignant liver (HCC) signed by imaging tests performed
* MELD scores greater than 30.
18 Years
69 Years
ALL
No
Sponsors
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Rio de Janeiro State Research Supporting Foundation (FAPERJ)
OTHER_GOV
Guilherme Rezende
OTHER
Responsible Party
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Guilherme Rezende
Associate Professor, MD PhD
Principal Investigators
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Guilherme FM Rezende, MD PhD
Role: STUDY_CHAIR
Universidade Federal do Rio de Janeiro
Locations
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Hospital Universitário Clementino Fraga Filho / Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
Countries
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Other Identifiers
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CAAE 06343212.8.0000.5257
Identifier Type: REGISTRY
Identifier Source: secondary_id
HHL/UFRJ-04
Identifier Type: -
Identifier Source: org_study_id
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