Evaluation of Role of Transient Elastography (Fibroscan) in Differentiating Patients of Acute Severe Viral Hepatitis and Acute on Chronic Liver Failure
NCT ID: NCT01866072
Last Updated: 2013-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2013-05-31
2014-01-31
Brief Summary
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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.
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Detailed Description
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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 .
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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AVH
AVH: Patients with Acute Viral Hepatitis
No interventions assigned to this group
ACLF
ACLF: Patients with Acute on Chronic Liver Failure
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient fail to give written consent.
18 Years
70 Years
ALL
No
Sponsors
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Sir Ganga Ram Hospital
OTHER
Responsible Party
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Dr. Praveen Shrama
Associate professor & Consultant
Principal Investigators
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Anil Arora, M.D
Role: PRINCIPAL_INVESTIGATOR
Deptartment of gastroenterology & hepatology, Sir Ganga Ram Hospital
Praveen Sharma, M.D
Role: PRINCIPAL_INVESTIGATOR
Department of Gatroenterology & Hepatology, Sir Gnaga Ram Hospital
Locations
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Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
New Delhi, New Delhi, India
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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EC/01/13/455
Identifier Type: -
Identifier Source: org_study_id
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