Clinical trial NCT01866072: Evaluation of Role of Transient Elastography (Fibroscan) in Differentiating Patients of Acute Severe Viral Hepatitis and Acute on Chronic Liver Failure
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Severe Viral Hepatitis
Acute on Chronic Liver Failure
Keywords: ACLF
AVH
Fibroscan
Transient elastography
Lead sponsor: Sir Ganga Ram Hospital
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Acute severe viral hepatitis or acute on chronic liver failure

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Fibroscan value at admission
timeFrame: 1st Day
Secondary outcomes:
measure: Fibroscan value at week 1
timeFrame: 1st week
measure: Fibroscan value at week 4
timeFrame: 4th week
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
Study officials:
affiliation: Deptartment of gastroenterology & hepatology, Sir Ganga Ram Hospital
name: Anil Arora, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Gatroenterology & Hepatology, Sir Gnaga Ram Hospital
name: Praveen Sharma, M.D
role: PRINCIPAL_INVESTIGATOR
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