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

Acute on Chronic Liver Failure Clinical Trial

— ACLF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01866072
• Other study ID #: EC/01/13/455
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2013
• Last updated: June 3, 2013
• Start date: May 2013
• Est. completion date: January 2014

Study information

• Verified date: June 2013
• Source: Sir Ganga Ram Hospital
• Contact: Praveen Sharma, M.D
• Phone: 091-9540951004
• Email: drpraveen_sharma[@]yahoo.com
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute Severe Viral Hepatitis
• End Stage Liver Disease
• Hepatitis
• Hepatitis A
• Liver Failure

Locations

Country	Name	City	State
India	Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Sir Ganga Ram Hospital

Country where clinical trial is conducted

India, 

References & Publications (8)

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. — View Citation

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. Review. — View Citation

de Lédinghen 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

McDONOUGH PG, Tho PT, Byrd JR. Twins discordant for 46,XX gonadal dysgenesis. Fertil Steril. 1977 Mar;28(3):251-2. — View Citation

Roulot D, Czernichow S, Le Clésiau 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Fibroscan value at week 1	2nd fibroscan will be done at week 1 from date of admission.	1st week	No
Secondary	Fibroscan value at week 4	3rd Fibroscan will be done at 4th week from date of admission.	4th week	No