Prediction of Mortality in Patients Waiting for Liver Transplantation Through Brain Magnetic Resonance Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-02-28

Brief Summary

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The purpose of this study is to determine whether hepatic encephalopathy, measured through magnetic resonance imaging, electroencephalogram and neuropsychological evaluation adds prognostic information to patients who are waiting for liver transplantation. If this model improves mortality prediction this might be used in the future for organ allocation.

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Detailed Description

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The only current definitive treatment for end-stage liver disease is transplantation. Due to the scarcity of organs available, the correct prioritization of patients for liver transplantation has a crucial importance. Nowadays, patients are ranked according to severity of liver disease, measured by the MELD score. This index is only derived from objective measures (serum concentration of bilirubin, creatinine and INR). Hepatic encephalopathy (HE) is a serious and progressive disorder in patients with end-stage liver disease. The severity of HE has prognostic implications in those waiting for liver transplantation. However, the prognosis of HE is independent and not correlated to the MELD score. Hepatic encephalopathy triggers multiple changes in brain magnetic resonance imaging (MRI) providing an objective way to evaluate it. Also electroencephalogram and neuropsychological evaluation might increase mortality prediction.

Adding the information provided by MRI, electroencephalogram and neuropsychological evaluation to the MELD score model might increase the prediction of mortality. Increase mortality's prediction has a fundamental importance because in organ allocation.

We will evaluate the predictive value of these variables in predicting mortality of those patients waiting for liver transplantation.

Conditions

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End Stage Liver Disease Hepatic Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liver transplantation waiting list

Patients waiting for liver transplantation with chronic end staged liver disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Man or woman over 18 years old
* Listed in liver transplantation waiting line
* Patient able and willing to participate in the evaluations of this study

Exclusion Criteria

* Acute liver failure
* Serious structural brain anomalies
* Condition or situation in which, in the opinion of the investigator, put the patient at significant risk

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No