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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Failure; Cirrhosis; Portal Hypertension

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21941-913
      • Hospital Universitário Clementino Fraga Filho / Federal University of Rio de Janeiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cirrhotic patients on the liver transplantation waiting list of a single center.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guilherme Rezende
• Collaborators: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Investigators: Study Chair: Guilherme FM Rezende, MD PhD, Universidade Federal do Rio de Janeiro

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: January 22, 2013
• First Submitted That Met QC Criteria: January 22, 2013
• First Posted (Estimate): January 24, 2013

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: portal hypertension; elastography; Hepatic venous pressure gradient measurement
• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Hypertension; Liver Failure; Hypertension, Portal
• Other Study ID Numbers: HHL/UFRJ-04; CAAE 06343212.8.0000.5257 (Registry Identifier: Plataforma Brasil CEP/CONEP)