What is the indication for FibroScan (Fibrosis Scan) in patients with chronic liver diseases?

Indications for FibroScan in Chronic Liver Disease

FibroScan is indicated for non-invasive assessment of liver fibrosis in patients with identified risk factors for chronic liver disease, including those with metabolic syndrome, harmful alcohol use, chronic viral hepatitis B or C, and persistently elevated liver enzymes. 1, 2

Primary Clinical Indications by Disease Category

Non-Alcoholic Fatty Liver Disease (NAFLD)

• Calculate FIB-4 score first using routine labs (AST, ALT, platelet count, age) in all adults with suspected or confirmed NAFLD 1, 2
• Proceed to FibroScan when FIB-4 is ≥1.3 (or ≥2.0 in patients aged ≥65 years) to identify patients requiring hepatology referral 1, 2
• FibroScan cutoff >7.0 kPa identifies significant fibrosis (≥F2) requiring closer monitoring 1, 2
• FibroScan <8.0 kPa reliably rules out advanced fibrosis with 93% sensitivity 2, 3

Alcohol-Related Liver Disease (ALD)

• Perform FibroScan immediately in patients drinking at harmful levels (≥35 units/week for women, ≥50 units/week for men) without requiring initial FIB-4 screening 2
• FibroScan cutoff <8.0 kPa reliably excludes advanced fibrosis 2
• Avoid testing during active alcohol consumption; ideally perform after 2 weeks of abstinence to prevent falsely elevated readings 2

Chronic Viral Hepatitis B and C

• Use APRI score >0.5 or FibroScan >7.0 kPa to identify significant fibrosis (≥F2) requiring antiviral treatment 1, 2
• Use APRI score >1.0 or FibroScan >12.5 kPa to identify cirrhosis (F4) requiring HCC screening and variceal surveillance 1, 2
• FibroScan demonstrates sensitivity/specificity of 70%/84% for significant fibrosis and 87%/91% for cirrhosis in viral hepatitis 2
• In chronic hepatitis B "gray zone patients" with ALT 1-2 times upper limit of normal, FibroScan determines whether antiviral therapy should be initiated 2

Risk Stratification Pathway for Primary Care

The algorithmic approach recommended by EASL: 1

1. Identify risk factors: metabolic syndrome, harmful alcohol use, HBV, HCV, family history of liver disease 1
2. Check baseline labs: AST, ALT, GGT, ALP, platelet count 1
3. For metabolic factors and/or alcohol only: Calculate FIB-4 first 1
   • FIB-4 <1.3: Low risk, repeat in 2-3 years if risk factors persist 2, 4
   • FIB-4 1.3-2.67: Indeterminate, proceed to FibroScan 1, 2
   • FIB-4 >2.67: High risk, refer to hepatology regardless of FibroScan 2
4. Consider combining with patented serum tests (ELF™, FibroTest™) when available for concordance/discordance analysis 1

Critical Technical Validity Requirements

A FibroScan result is only reliable when ALL three criteria are met: 2, 4

• ≥10 successful measurements obtained
• Success rate ≥60%
• Interquartile range <30% of median value

Common causes of unreliable or failed measurements: 2, 5, 6

• Obesity (BMI >28 kg/m²)—consider XL probe with cutoffs 1.2-1.3 kPa lower than standard M probe 6
• Ascites (absolute contraindication) 2, 4
• Narrow intercostal spaces 2, 4
• Acute hepatitis or ALT flare (can falsely elevate readings to cirrhotic range) 6
• Extrahepatic biliary obstruction 2, 4

Interpretation Thresholds for Clinical Decision-Making

Fibrosis Staging Cutoffs 2, 4

• <7.0-8.0 kPa: Rules out significant fibrosis (F0-F1)
• >7.0 kPa: Significant fibrosis (≥F2) present
• 8.0-12.0 kPa: Advanced fibrosis (F3)
• >12.5 kPa: Cirrhosis (F4)—requires urgent hepatology referral and HCC screening

Disease-Specific Cutoffs

For chronic hepatitis B/C: 1

• 7.0 kPa for significant fibrosis (≥F2)

• 12.5 kPa for cirrhosis (F4)

For NAFLD: 2, 3

• <8.0 kPa excludes advanced fibrosis
• 8.2 kPa optimal cutoff for detecting ≥F2

For cirrhosis complications: 7

• 27.5 kPa: esophageal varices grade 2/3
• 37.5 kPa: Child-Pugh B or C cirrhosis
• 49.1 kPa: history of ascites
• 53.7 kPa: hepatocellular carcinoma
• 62.7 kPa: esophageal bleeding

Patient Preparation Requirements

• Fast for at least 4 hours before examination, as food intake increases hepatic blood flow and falsely elevates liver stiffness 2
• Patient lies supine with right arm raised in maximal abduction 2
• Measurements taken at 1.5-2 cm depth below liver capsule, avoiding <1 cm depth due to reverberation artifacts 2

Common Pitfalls to Avoid

Do not rely on FibroScan alone to rule out other causes of liver disease—it only measures stiffness, not inflammation or alternative diagnoses 2

Ensure comprehensive etiologic workup is performed before or in parallel with FibroScan to avoid spectrum effect and false positives in unselected populations 1

Recognize confounding factors that falsely elevate readings: 2, 6

• Recent alcohol consumption
• Active hepatic inflammation or ALT flare
• Hepatic congestion
• Extrahepatic cholestasis

In chronic hepatitis B with elevated ALT (up to 5× ULN), use higher cutoff values to avoid falsely diagnosing cirrhosis during ALT flare 6

Follow-Up Monitoring Intervals

• Low-risk patients (FibroScan <7.8 kPa): Repeat pathway in 3-5 years if risk factors remain 2
• Mild fibrosis (F0-F1): Repeat FibroScan every 2-3 years 4
• Patients with multiple risk factors or borderline values (7-8 kPa): More frequent monitoring every 6-12 months 4
• Advanced fibrosis or cirrhosis: Annual monitoring with hepatology co-management 4

Prognostic Value Beyond Staging

FibroScan provides critical prognostic information for predicting: 7, 6

• Development of hepatocellular carcinoma
• Portal hypertension and variceal bleeding risk
• Post-operative complications in HCC patients
• Overall survival in cirrhotic patients

The WHO Guideline Development Group concluded that benefits of non-invasive testing—including increased treatment availability, reduced need for liver biopsy, and decreased adverse events—outweigh potential harms of false-positive results and unnecessary treatment. 1