Evaluation of Role of Transient Elastography (Fibroscan) in Differentiating Patients of Acute Severe Viral Hepatitis and Acute on Chronic Liver Failure (ACLF)
|ClinicalTrials.gov Identifier: NCT01866072|
Recruitment Status : Unknown
Verified June 2013 by Dr. Praveen Shrama, Sir Ganga Ram Hospital.
Recruitment status was: Recruiting
First Posted : May 31, 2013
Last Update Posted : June 4, 2013
Transient elastography is novel non-invasive method for assessment of hepatic fibrosis in patients with chronic liver disease, by measuring liver stiffness. Transient elastography is a user friendly technique that can be easily performed at bedside or in outpatient clinic with immediate results and good reproducibility.
Liver stiffness values ranges from 2.5 to 75 kPa with lower values <6kPa suggest no fibrosis where as higher values above 14kPa suggests cirrhosis. In the present study the investigators hypothesis that the investigators can differentiate ACLF and acute severe viral hepatitis based on fibroscan as patients with underlying fibrosis with superadded inflammation would have higher fibroscan value than when patient have only inflammation with no underlying fibrosis and hence the investigators can avoid unnecessary test in such subgroup.
|Condition or disease|
|Acute Severe Viral Hepatitis Acute on Chronic Liver Failure|
Transient elastography is a novel non-invasive method that for the assessment of hepatic fibrosis in patients with chronic liver diseases, by measuring liver stiffness.
Acute on chronic liver failure: acute hepatic insult manifesting as jaundice and coagulopathy, complicated within 4 weeks by ascites and/or encephalopathy in patients with previously diagnosed or undiagnosed chronic liver disease.
Acute severe hepatitis: Acute severe hepatitis which is characterized by serum bilirubin > or = 10.0 mg/dL and international normalized ratio (INR) > or = 1.5.
Patients with acute severe viral hepatitis or acute on chronic liver failure will be enrolled in this prospective study after taking informed written consent. All patients will be evaluated at baseline as per standard protocol which include evaluation of etiology of disease and tests to exclude underlying liver disease which includes ultrasound/computed tomography and if necessary upper gastrointestinal endoscopy and liver biopsy if imaging shows any signs of underlying liver disease. the patients will be followed up for 1 month, all patients will undergo Fibroscan at the time of admission and thereafter at 1week and 4th week .
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||A Prospective Evaluation of the Role of Transient Elastography (Fibroscan) in Differentiating Patients of Acute Severe Viral Hepatitis and Acute on Chronic Liver Failure|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||January 2014|
AVH: Patients with Acute Viral Hepatitis
ACLF: Patients with Acute on Chronic Liver Failure
- Fibroscan value at admission [ Time Frame: 1st Day ]The patient enrolled will undergo fibroscan procedure and baseline fibroscan values will be measured at the time of admission.
- Fibroscan value at week 1 [ Time Frame: 1st week ]2nd fibroscan will be done at week 1 from date of admission.
- Fibroscan value at week 4 [ Time Frame: 4th week ]3rd Fibroscan will be done at 4th week from date of admission.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866072
|Contact: Praveen Sharma, M.Dfirstname.lastname@example.org|
|Contact: Anil Arora, M.Demail@example.com|
|Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital||Recruiting|
|New Delhi, India, 110060|
|Contact: Praveen Sharma, M.D 091-9540951004 firstname.lastname@example.org|
|Contact: Anil Arora, M.D 091-9311638779 email@example.com|
|Principal Investigator: Anil Arora, M.D|
|Sub-Investigator: Praveen Sharma, M.D|
|Principal Investigator:||Anil Arora, M.D||Deptartment of gastroenterology & hepatology, Sir Ganga Ram Hospital|
|Principal Investigator:||Praveen Sharma, M.D||Department of Gatroenterology & Hepatology, Sir Gnaga Ram Hospital|