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

Guilherme Rezende

Status: Completed

Conditions: Portal Hypertension; Cirrhosis; Liver Failure

Study type: Observational

Funder types: Other

Identifiers

NCT01774617

HHL/UFRJ-04

CAAE 06343212.8.0000.5257 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No 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.

Trial design

80 participants in 1 patient group

Patients with advanced liver disease

Description:

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.