NASH cirrhosis is the end stage of NASH, and NASH itself is fast becoming the most frequent etiology of liver cirrhosis. If a patient has NASH or is suspected of having NASH, concern about cirrhosis can be raised by the consistency of the liver at palpation. A healthy liver is soft; a cirrhotic liver will feel hard to the touch.
Two simple tests can also be supportive of a NASH cirrhosis diagnosis:
The progression of cirrhosis, regardless of etiology, is often defined by clinical outcomes. In particular, cirrhosis can be said to have compensated and decompensated stages, both with different features, prognoses, and predictors of death.
In compensated cirrhosis, patients have yet to experience the more serious symptoms of NASH cirrhosis; indeed, they may appear asymptomatic.
Decompensated cirrhosis, on the other hand, is characterized by the development of clinical complications of portal hypertension, such as ascites, variceal hemorrhage, hepatic encephalopathy, or liver failure. The more severe stage of decompensated cirrhosis is defined by the development of recurrent variceal hemorrhage, refractory ascites, hyponatremia, and hepatorenal syndrome.
One study found that patients with compensated cirrhosis had an expected one-year mortality rate of 5.4%. In decompensated cirrhosis, the one-year mortality was around 20%. Compensated patients with no esophageal varices had a longer survival than patients with varices.
The goal in treating NASH cirrhosis, therefore, is to maintain the patient in the compensated cirrhotic stage as long as possible or, potentially, reverse the cirrhotic process. The development of small esophageal varices is seen as clinical evidence that a patient is on the verge of decompensating.
The NAVIGATE Study is focused on preventing the development of esophageal varices in patients with compensated NASH cirrhosis. No varices means no potential for bleeding varices, a cause of death in a third of NASH cirrhosis patients.
If you think that participation in the NAVIGATE Study is appropriate for your patient, contact one of the trial sites convenient to the patient to begin the initial screening.
See clinicaltrials.gov for a full list of currently active study sites and their contact information.
Study sites for the NAVIGATE Study are currently located throughout the U.S. Sites are also participating in Canada, Mexico, and the rest of the world.