Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01866072
Acronym
ACLF
Enrollment
100
Registered
2013-05-31
Start date
2013-05-31
Completion date
2014-01-31
Last updated
2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute on Chronic Liver Failure, Acute Severe Viral Hepatitis

Keywords

ACLF, AVH, Fibroscan, Transient elastography

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 .

Interventions

None listed

Sponsors

Sir Ganga Ram Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fibroscan value at admission1st DayThe patient enrolled will undergo fibroscan procedure and baseline fibroscan values will be measured at the time of admission.

Secondary

MeasureTime frameDescription
Fibroscan value at week 11st week2nd fibroscan will be done at week 1 from date of admission.
Fibroscan value at week 44th week3rd Fibroscan will be done at 4th week from date of admission.

Countries

India

Contacts

Primary ContactPraveen Sharma, M.D
drpraveen_sharma@yahoo.com091-9540951004
Backup ContactAnil Arora, M.D
dranilarora50@gmail.com091-9311638779

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026