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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110060
    • Recruiting
    • Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
    • Contact: Praveen Sharma, M.D; Phone Number: 091-9540951004; Email: drpraveen_sharma@yahoo.com
    • Contact: Anil Arora, M.D; Phone Number: 091-9311638779; Email: dranilarora50@gmail.com
    • Principal Investigator: Anil Arora, M.D
    • Sub-Investigator: Praveen Sharma, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Acute severe viral hepatitis or acute on chronic liver failure

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
AVH; AVH: Patients with Acute Viral Hepatitis
ACLF; ACLF: Patients with Acute on Chronic Liver Failure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibroscan value at week 1	2nd fibroscan will be done at week 1 from date of admission.	1st week
Fibroscan value at week 4	3rd Fibroscan will be done at 4th week from date of admission.	4th week

Collaborators and Investigators

• Sponsor: Sir Ganga Ram Hospital
• Investigators: 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

Publications and helpful links

General Publications

• Roulot D, Czernichow S, Le Clesiau H, Costes JL, Vergnaud AC, Beaugrand M. Liver stiffness values in apparently healthy subjects: influence of gender and metabolic syndrome. J Hepatol. 2008 Apr;48(4):606-13. doi: 10.1016/j.jhep.2007.11.020. Epub 2008 Jan 3.
• Arena U, Vizzutti F, Corti G, Ambu S, Stasi C, Bresci S, Moscarella S, Boddi V, Petrarca A, Laffi G, Marra F, Pinzani M. Acute viral hepatitis increases liver stiffness values measured by transient elastography. Hepatology. 2008 Feb;47(2):380-4. doi: 10.1002/hep.22007.
• Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26.
• Kumar M, Satapathy S, Monga R, Das K, Hissar S, Pande C, Sharma BC, Sarin SK. A randomized controlled trial of lamivudine to treat acute hepatitis B. Hepatology. 2007 Jan;45(1):97-101. doi: 10.1002/hep.21486.
• Kumar M, Sharma P, Garg H, Kumar R, Bhatia V, Sarin SK. Transient elastographic evaluation in adult subjects without overt liver disease: influence of alanine aminotransferase levels. J Gastroenterol Hepatol. 2011 Aug;26(8):1318-25. doi: 10.1111/j.1440-1746.2011.06736.x.
• de Ledinghen V, Vergniol J. Transient elastography for the diagnosis of liver fibrosis. Expert Rev Med Devices. 2010 Nov;7(6):811-23. doi: 10.1586/erd.10.46.
• Garg H, Kumar A, Garg V, Sharma P, Sharma BC, Sarin SK. Clinical profile and predictors of mortality in patients of acute-on-chronic liver failure. Dig Liver Dis. 2012 Feb;44(2):166-71. doi: 10.1016/j.dld.2011.08.029. Epub 2011 Oct 5.
• McDONOUGH PG, Tho PT, Byrd JR. Twins discordant for 46,XX gonadal dysgenesis. Fertil Steril. 1977 Mar;28(3):251-2. doi: 10.1016/s0015-0282(16)42434-9.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): November 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: May 28, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): June 4, 2013
• Last Update Submitted That Met QC Criteria: June 3, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Transient elastography; ACLF; Fibroscan; AVH
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Liver Failure, Acute; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Hepatitis; Hepatitis A
• Other Study ID Numbers: EC/01/13/455