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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01774617

Enrollment

Registered

2013-01-24

Start date

2015-12-31

Completion date

2018-11-30

Last updated

2020-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver Failure, Portal Hypertension

Keywords

portal hypertension, elastography, Hepatic venous pressure gradient measurement

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results