The Use of Transient Elastography to Predict Clinical Decompensation in Patients With Early Cirrhosis
Withdrawn before enrolling
Conditions studied: Cirrhosis
In brief
This is a prospective study designed to examine the role of transient elastography as a predictor of clinical decompensation in patients with early cirrhosis. The study objective is to determine if changes in measurements of liver stiffness with transient elastography can identify patients that will have a more rapid progression of cirrhosis and the development of clinical decompensation. The target population is patients with early stage, well-compensated cirrhosis. Participants of this study will be asked to complete the following procedures: read and sign the informed consent, medical records review (complete medical history, physical examination, laboratory evaluation, endoscopic findings, radiographic findings), undergo transient elastography to measure liver stiffness every three months until the development of clinical decompensation (ascites, variceal bleeding, hepatorenal syndrome, overt hepatic encephalopathy) for up to 2 years.
Key facts
- Study ID
- NCT02258048
- Run by
- NYU Langone Health
- People needed
- 0
- Starts
- 2014-10-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2016-03-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ambulatory patients with histologic or radiographic evidence of cirrhosis will be screened for participation in the study.
- Able to provide informed consent
- MELD score <10
- No history of ascites, variceal bleeding, hepatorenal syndrome, overt hepatic encephalopathy.
You may not qualify if…
- History of variceal bleeding, ascites, hepatorenal syndrome, or overt hepatic encephalopathy
- Inability to provide informed consent
- Body mass index (BMI)>35
Where it is running
- NYU Langone Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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