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Medical Writers' Circle

Use of Fibroscan® in Clinical Practice

Maurizio Bonacini, MD
University of California, San Francisco Gastroenterology and Hepatology

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The FibroScan® is a non invasive modality which measures fibrosis of the liver by assessing parenchymal (tissue) stiffness. It has been evaluated in more than 400 peer-reviewed articles in most types of liver disease [1-12]. In April 2013, the Food and Drug Administration approved its use in the U.S., stating "FibroScan® is indicated for the measurement of shear wave speed in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease."

FibroScan® is a painless, rapid test (about 15 minutes) which can be used to classify patients in terms of the severity of their liver fibrosis.

The "shear waves" created by the FibroScan® 502 machine measure the elasticity of the liver using a technique called Vibration-Controlled Transient Elastography (VCTE™). The measurement unit is the kPa (kilopascals): the higher the number, the more advanced is the liver fibrosis. It is important to recognize that the stiffness levels vary according to the type of liver disease. For example, the cutoff for cirrhosis is lower in hepatitis C (HCV) and higher for alcoholic liver disease (ALD), as noted in the tables below.

Liver biopsy has long been the gold standard to stage fibrosis in the liver. The disadvantages of biopsy are:

  1. It is an invasive test,
  2. It requires the patient to be hospitalized for half a day,
  3. It is expensive ($3,000),
  4. It is associated with certain risks, such as pain (20%) and bleeding (1%) which often require hospitalization
  5. Death has been reported in 1/10,000 biopsies.
  6. In addition, a liver biopsy samples only a very small piece of the liver, which can lead to incorrect staging if this sample is not representative of the rest of the liver. Thus, liver biopsy can lead to sampling error, which may result in understaging of fibrosis; sampling error may occur in up to 25-30% of liver biopsies. Another limitation of liver biopsy is that different pathologists can interpret the same sample differently, which can result in discrepancies in liver disease staging.

FibroScan® offers several advantages compared to liver biopsy:

  1. FibroScan® is a noninvasive test, it can be performed at the point of care,
  2. There is no pain, and sedation is not required.
  3. The test takes only 15 minutes to perform
  4. It is significantly less expensive than liver biopsy
  5. It hasn't been associated with any side effects.
  6. The results of the test are instantaneous, so clinicians can use them to make decisions during patients' visits.

However, FibroScan® does have some limitations:

  1. It is not as accurate as needle biopsy for those with mid-level liver disease.
  2. It is not advised for patients with ascites, and/or morbid obesity.

The references below represent the most authoritative publications (including meta-analysis) on the performance of FibroScan® compared to other modalities [1-12]. The following have endorsed the use of FibroScan®:

  • The FDA approved this technique in 2013
  • Dr. Kurt J. Isselbacher, former Editor-in-chief of the New England Journal of Medicine: "FibroScan® has the potential to revolutionize the care of patients with chronic liver disease by improving the management of their disease and lowering the cost of their care."
  • AbbVie as well as other pharmaceutical companies use FibroScan® in their HCV clinical trials to stratify patients with different fibrosis stages
  • NIH: "Elastography represents a significant step forward in attempting to overcome some of the deficiencies associated with needle liver biopsy" [13]

Recommendations for the use of FibroScan®:
References are in [ ]; HCV= Hepatitis C; HBV=Hepatitis B; NPV=Negative predictive value; PPV=Positive predictive value; US=ultrasound; AFP=Alfafetoprotein; F=fibrosis stage; HTN=hypertension

Hepatitis C (HCV)

Stiffness Indicates Advice
>12.9 [1,4] Cirrhosis
NPV=95%
US and AFP every 6 months for surveillance of Liver cancer
Strongly consider HCV therapy
≥9.6  [2] Advanced fibrosis   ≥F2 Strongly consider HCV therapy
<7.1 [2] Lower level of fibrosis  <F2 
PPV >90%
Consider HCV therapy vs. observation

Hepatitis B (HBV)

Stiffness Indicates Advice
>12.9   [3,4] Cirrhosis
NPV=94%
US and AFP every 6 months for surveillance of Liver cancer
Strongly consider HBV therapy
≥7.3      [5] ≥ F2     PPV=94% Strongly consider HBV therapy
5.3-7.2 Lower level of fibrosis Observation if low HBV viremia
Repeat FibroScan® in 1 year
<5.3     [5] < F2  NPV=83% Observation if low HBV viremia

Non alcoholic fatty Liver (NAFLD)

Stiffness Indicates Advice
>10.2  [6] Cirrhosis
NPV=99%
Refer to Hepatology
US and AFP every 6 months for surveillance of Liver cancer
≥ 7.9    [7] ≥F3
NPV=97%
Refer to Hepatology, may need therapy (e.g. Vitamin E) or enter clinical trial
6-7.8 F2 May observe in primary care
Repeat FibroScan® in 1 year
<6 Lower level of fibrosis Observe in primary care
Diet and exercise. Diabetes and hyperlipidemia control

Alcoholic liver disease (ALD)

Stiffness Indicates Advice
>18.7 [8,9] Cirrhosis
PPV=90%
US and AFP every 6 months for surveillance of Liver cancer
Stop all alcohol
12.7-18.7 [8,9] ≥F3
Advanced fibrosis
PPV=92%
Stop all alcohol
Consider US and AFP every 12 months for surveillance of Liver cancer
>8.2-12.6 ≥F2
Advanced fibrosis
PPV=100%
Stop all alcohol

Any cirrhosis:

Stiffness Indicates Advice
<18 kPa   [10] Cirrhosis Very low chance of complications due to portal HTN (6%)
≥18 kPa Advanced cirrhosis High chance of complications due to portal HTN (40-50%): recommend endoscopy to detect esophageal varices

References:

1. Steadman R, et al. A health technology assessment of transient elastography in adult liver disease. Can J Gastroenterol 2013;27:149-158.

2. Nitta Y et al. Liver stiffness measured by transient elastography correlates with fibrosis area in liver biopsy in patients with chronic hepatitis C. Hepatology Research 2009;39:675–684.

3. Lee S, Kim DY. Non invasive diagnosis of hepatitis B virus-related cirrhosis. World J Gastroenterol 2014;20:445-459.

4. Degos F et al. Diagnostic accuracy of FibroScan® and comparison to liver fibrosis biomarkers  in chronic viral hepatitis: The Fibrostic study. J Hepatol 2010;53:1013-21.

5. Bonnard P, et al. Comparison of elastography, serum markers scores, and histology for the assessment of liver fibrosis in hepatitis B virus (HBV)-infected patients. Am J Trop Hyg 2010;82:454-58.

6. Wong GL. Update of liver fibrosis and steatosis with transient elastography (FibroScan®). Gastroenterol  Rep 2013;1:19-26.

7. Wong VW et al. Diagnosis of fibrosis and cirrhosis using liver stiffnes measurement in nonalcoholic fatty liver disease. Hepatology 2010;51:454-62.

8. Nahon P. Assessment of liver fibrosis using transient elastography in patients with alcoholic liver disease. J Hepatol. 2008;49(6):1062-8.

9. Nguyen-Khac E et al. Assessment of Asymptomatic Liver Fibrosis in Alcoholic Patients Using FibroScan®: Prospective Comparison With Seven Non-Invasive Laboratory Tests. Aliment Pharmacol Ther. 2008;28(10):1188-1198.

10. Kang W, Kim SU, Ahn SH. Non-invasive prediction of forthcoming cirrhosis-related complications. World J Gastroenterol 2014;20:2613-23.

11. Castera L. Noninvasive Methods to Assess Liver Disease in Patients With Hepatitis B or C. Gastroenterology 2012; 142:1293-1302.

12. Friedrich-Rust M et al. Performance of Transient Elastography for the Staging of Liver Fibrosis: A Meta-Analysis. Gastroenterology 2008;134:960–974.

13. Ghany M and Doo E.  Assessment of liver fibrosis: Palpate, poke or pulse? Hepatology 2005;42:759-60.

 

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