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

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ClinicalTrials.gov Identifier: NCT01866072
Recruitment Status : Unknown
Verified June 2013 by Dr. Praveen Shrama, Sir Ganga Ram Hospital.
Recruitment status was:  Recruiting
First Posted : May 31, 2013
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Praveen Shrama, Sir Ganga Ram Hospital

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.


Condition or disease
Acute Severe Viral Hepatitis Acute on Chronic Liver Failure

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 .

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
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 Start Date : May 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Fibroscan value at admission [ Time Frame: 1st Day ]
    The patient enrolled will undergo fibroscan procedure and baseline fibroscan values will be measured at the time of admission.


Secondary Outcome Measures :
  1. Fibroscan value at week 1 [ Time Frame: 1st week ]
    2nd fibroscan will be done at week 1 from date of admission.

  2. Fibroscan value at week 4 [ Time Frame: 4th week ]
    3rd Fibroscan will be done at 4th week from date of admission.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Acute severe viral hepatitis or acute on chronic liver failure
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866072


Contacts
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Contact: Praveen Sharma, M.D 091-9540951004 drpraveen_sharma@yahoo.com
Contact: Anil Arora, M.D 091-9311638779 dranilarora50@gmail.com

Locations
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India
Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital Recruiting
New Delhi, India, 110060
Contact: Praveen Sharma, M.D    091-9540951004    drpraveen_sharma@yahoo.com   
Contact: Anil Arora, M.D    091-9311638779    dranilarora50@gmail.com   
Principal Investigator: Anil Arora, M.D         
Sub-Investigator: Praveen Sharma, M.D         
Sponsors and Collaborators
Sir Ganga Ram Hospital
Investigators
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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:

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Responsible Party: Dr. Praveen Shrama, Associate professor & Consultant, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT01866072    
Other Study ID Numbers: EC/01/13/455
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013
Keywords provided by Dr. Praveen Shrama, Sir Ganga Ram Hospital:
ACLF
AVH
Fibroscan
Transient elastography
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Failure, Acute