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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-11-30

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.

Detailed Description

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Conditions

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Cirrhosis Liver Failure Portal Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Guilherme Rezende

OTHER

Sponsor Role lead

Responsible Party

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Guilherme Rezende

Associate Professor, MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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Brazil

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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