CirrhosisNCT01774617
Comparative Analysis of Different Tests to Evaluate Prognosis of Patients on Liver Transplant Waiting List
An observational study of Cirrhosis and Liver Failure, run by Guilherme Rezende at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Cirrhosis, Liver Failure, Portal Hypertension
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2015to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhotic patients on the liver transplantation waiting list of a single center.
Who may be able to join
- 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
Who cannot join
- they have been transplanted
- have a diagnosis of primary malignant liver (HCC) signed by imaging tests performed
- MELD scores greater than 30.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário Clementino Fraga Filho / Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-913
About this study
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
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.
- Conditions
- Cirrhosis, Liver Failure, Portal Hypertension
- Keywords
- portal hypertension, elastography, Hepatic venous pressure gradient measurement
- Medical subject headings
- Fibrosis, Liver Failure, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Mortality within 6 months after evaluation, classifying as related or non-related to liver disease
Measured: 6 months
Secondary outcomes (1)
Chronic liver failure and portal hypertension complications
Complications:
- gastroesophageal variceal bleeding
- worsening of hepatic encephalopathy
- decompensated ascites and spontaneous bacterial peritonitis
- hepatorenal syndrome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startDec 2015
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guilherme Rezende
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Sponsor-investigator, Guilherme Rezende, Universidade Federal do Rio de Janeiro
- Investigators
- Guilherme FM Rezende, MD PhD, Study chair, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774617
- Sponsor's protocol ID
- HHL/UFRJ-04
- Other IDs
- CAAE 06343212.8.0000.5257
- Status last verified
- Oct 2020
- First submitted
- 22 Jan 2013
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01774617
- Acronym / sponsor ID
- HHL/UFRJ-04
- Conditions
- Cirrhosis, Liver Failure, Portal Hypertension
- Keywords
- portal hypertension, elastography, Hepatic venous pressure gradient measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Guilherme RezendeUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Dec 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic patients on the liver transplantation waiting list of a single center.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- they have been transplanted
- have a diagnosis of primary malignant liver (HCC) signed by imaging tests performed
- MELD scores greater than 30.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality
Time frame: 6 months
Mortality within 6 months after evaluation, classifying as related or non-related to liver disease
1 secondary outcome
Chronic liver failure and portal hypertension complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilherme FM Rezende, MD PhD study chair
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Liver Failure, run by Guilherme Rezende at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.