Evaluation of Role of Transient Elastography (Fibroscan) in Differentiating Patients of Acute Severe Viral Hepatitis and Acute on Chronic Liver Failure

• Conditions: Acute Severe Viral Hepatitis; Acute on Chronic Liver Failure

• Registration Number: NCT01866072
• Lead Sponsor: Sir Ganga Ram Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-05-31
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-03
• Last Update Posted: 2013-06-04
• Primary Completion: 2013-11
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient's age 18-70years.
• Patients with a diagnosis of acute severe viral hepatitis or acute on chronic liver failure.
• Patients willing for informed consent and follow up for 1 month.

Exclusion Criteria

• Patients with gross ascites, hepatic encephalopathy.
• Patient fail to give written consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fibroscan value at admission	1st Day	The patient enrolled will undergo fibroscan procedure and baseline fibroscan values will be measured at the time of admission.

Secondary Outcome Measures

Name	Time	Method
Fibroscan value at week 1	1st week	2nd fibroscan will be done at week 1 from date of admission.
Fibroscan value at week 4	4th week	3rd Fibroscan will be done at 4th week from date of admission.

Trial Locations

Locations (1)

Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital; 🇮🇳 New Delhi, India