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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01866072
Other study ID # EC/01/13/455
Secondary ID
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


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
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