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

Sponsor

Guilherme Rezende (Other)

Overall Status

Completed

CT.gov ID

NCT01774617

Collaborator

Rio de Janeiro State Research Supporting Foundation (FAPERJ) (Other)

Enrollment

Location

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis Liver Failure Portal Hypertension

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Nov 1, 2018

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

All cause mortality [6 months]
Mortality within 6 months after evaluation, classifying as related or non-related to liver disease

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitário Clementino Fraga Filho / Federal University of Rio de Janeiro	Rio de Janeiro	RJ	Brazil	21941-913

Sponsors and Collaborators

Guilherme Rezende
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Investigators

Study Chair: Guilherme FM Rezende, MD PhD, Universidade Federal do Rio de Janeiro

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guilherme Rezende, Associate Professor, MD PhD, Universidade Federal do Rio de Janeiro

ClinicalTrials.gov Identifier:

NCT01774617

Other Study ID Numbers:

HHL/UFRJ-04
CAAE 06343212.8.0000.5257

First Posted:

Jan 24, 2013

Last Update Posted:

Oct 9, 2020

Last Verified:

Oct 1, 2020

Keywords provided by Guilherme Rezende, Associate Professor, MD PhD, Universidade Federal do Rio de Janeiro

portal hypertension

elastography

Hepatic venous pressure gradient measurement

Additional relevant MeSH terms:

Liver Failure

Hypertension, Portal

Hypertension

Study Results

No Results Posted as of Oct 9, 2020