Definition/General

Introduction:
-Focal Nodular Hyperplasia (FNH) is the second most common benign liver lesion after hemangioma
-It represents a hyperplastic response to vascular malformation
-FNAC shows normal hepatocytes with bile ductules and Kupffer cells
-It is a non-neoplastic lesion with no malignant potential.
Origin:
-Arises from hyperplastic response to congenital arteriovenous malformation
-Represents polyclonal proliferation of hepatocytes
-Associated with central stellate scar containing artery and bile ducts
-Not a true neoplasm but rather hamartomatous proliferation
-Results from hyperperfusion injury.
Classification:
-Classified as classic FNH (90% cases) with central scar
-Non-classic FNH (10% cases): telangiectatic, mixed hyperplastic-adenomatous
-Multiple FNH (20% cases)
-Large FNH (>5 cm)
-Associated with hepatic adenomas in adenomatosis
-FNH-like nodules in cirrhotic livers.
Epidemiology:
-Second most common benign liver tumor (prevalence 0.9-8%)
-Strong female predominance (F:M = 8:1)
-Peak incidence in 3rd-4th decades
-Associated with oral contraceptive use
-Often discovered incidentally
-Stable lesion with no malignant potential
-Indian women: increasing detection with widespread imaging.

Clinical Features

Presentation:
-Usually completely asymptomatic (>95% cases)
-Incidental finding on imaging studies
-Rarely: vague right upper quadrant discomfort
-No hepatomegaly typically
-Normal liver function tests
-No association with hepatitis or cirrhosis
-Pregnancy-related growth rare.
Symptoms:
-Asymptomatic in vast majority
-Vague abdominal discomfort (large lesions, >8 cm)
-No constitutional symptoms
-Normal appetite and weight
-No nausea or vomiting
-No hormonal symptoms
-Rarely: mass effect symptoms in giant lesions.
Risk Factors:
-Oral contraceptive use (controversy regarding causation vs detection bias)
-Female gender (strong association)
-Reproductive age (20-50 years)
-Vascular malformations (underlying cause)
-No association with alcohol or hepatitis
-Genetic factors (familial cases rare).
Screening:
-Usually detected on routine imaging
-Ultrasound: isoechoic to hyperechoic mass
-CT triphasic: arterial enhancement with central scar
-MRI: T1 iso/hypointense, T2 iso/hyperintense
-Sulfur colloid scan: Kupffer cell uptake (pathognomonic)
-Normal AFP and other tumor markers.

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Gross Description

Appearance:
-FNAC yields highly cellular hepatocyte-rich aspirate
-Normal-appearing hepatocytes in sheets and trabeculae
-Bile ductules and cholangiocytes present
-Kupffer cells scattered throughout
-Background shows minimal blood and debris
-Fibrous tissue from central scar.
Characteristics:
-Cellular aspirate resembling normal liver parenchyma
-Hepatocytes: uniform size with abundant cytoplasm
-Bile ductules: small glandular structures
-Kupffer cells: stellate cells with pigment
-Endothelial cells lining sinusoids
-Fibrous connective tissue fragments.
Size Location:
-Variable size: typically 2-5 cm
-Any hepatic segment can be affected
-Subcapsular location common
-Well-demarcated from surrounding parenchyma
-Central stellate scar (pathognomonic feature)
-Multiple lesions in 20% cases.
Multifocality:
-Solitary lesion in 80% cases
-Multiple FNH in 20% cases
-Bilateral distribution when multiple
-Associated with hepatic adenomas (adenomatosis)
-Vascular anomalies may be present
-No extrahepatic manifestations typically.

Microscopic Description

Histological Features:
-Normal hepatocytes arranged in trabeculae and sheets
-Bland nuclear morphology with uniform size
-Bile ductules proliferation (cholangiolar proliferation)
-Kupffer cells with brown pigment (lipofuscin)
-Sinusoidal endothelial cells
-Fibrous connective tissue with vessels.
Cellular Characteristics:
-Hepatocytes: polygonal cells with abundant eosinophilic cytoplasm
-Central nuclei with prominent nucleoli
-Binucleated forms common (normal finding)
-Cholangiocytes: cuboidal cells lining bile ductules
-Kupffer cells: stellate morphology with pigment
-No cellular atypia or pleomorphism.
Architectural Patterns:
-Trabecular pattern mimicking normal liver architecture
-Nodular arrangement with fibrous septa
-Bile ductular proliferation at periphery of nodules
-Sinusoidal pattern preserved
-Central fibrous scar with vessels and bile ducts
-No mass effect or compression.
Grading Criteria:
-No grading system for FNH (benign lesion)
-Assessment based on architectural preservation
-Hepatocyte morphology: normal vs slightly enlarged
-Bile ductule density: increased vs normal
-Kupffer cell content: normal vs decreased
-Fibrous tissue amount: minimal vs prominent.

Immunohistochemistry

Positive Markers:
-Hepatocyte marker (positive in hepatocytes)
-Arginase-1 (hepatocyte marker)
-CK7 (positive in bile ductules)
-CK19 (cholangiocyte marker)
-CD68 (Kupffer cells)
-Glutamine synthetase (heterogeneous pattern, unlike adenoma).
Negative Markers:
-AFP (negative, excludes HCC)
-Glypican-3 (negative, excludes HCC)
-CD34 (negative in sinusoids, unlike adenoma)
-Cytokeratin 8/18 (variable in hepatocytes)
-Beta-catenin (membranous pattern)
-p53 (negative).
Diagnostic Utility:
-Limited utility in FNAC setting
-Hepatocyte marker confirms hepatocytic nature
-CK7/CK19 highlight bile ductules (key feature)
-Glutamine synthetase: heterogeneous (unlike adenoma's homogeneous)
-CD34 negativity helps vs adenoma
-Excludes HCC (AFP-, Glypican-3-).
Molecular Subtypes:
-No specific molecular subtypes
-Polyclonal lesion (not true neoplasm)
-Normal karyotype in most cases
-Telomerase activity absent
-No specific oncogene activation
-Vascular remodeling genes may be upregulated.

Molecular/Genetic

Genetic Mutations:
-No specific somatic mutations characteristic of FNH
-Polyclonal proliferation (reactive hyperplasia)
-Normal chromosomal profile
-Rare chromosomal imbalances (non-specific)
-Vascular malformation genes may be involved
-No tumor suppressor gene alterations.
Molecular Markers:
-Normal hepatocyte markers expression
-Angiogenesis factors: VEGF, angiopoietin
-Proliferation markers: low Ki-67 index
-Apoptosis markers: normal levels
-Matrix remodeling: collagen, fibronectin
-Cytochrome P450 enzymes normal.
Prognostic Significance:
-Excellent prognosis (benign lesion)
-No malignant transformation risk
-Stable size over time typically
-No liver dysfunction
-Pregnancy effect: minimal size change
-Oral contraceptive effect: controversial
-Complications extremely rare.
Therapeutic Targets:
-Observation for asymptomatic lesions
-No specific treatment needed
-Discontinue OCP if size increase
-Follow-up imaging to confirm stability
-Surgery only for symptomatic giant lesions
-No chemotherapy or targeted therapy needed.

Differential Diagnosis

Similar Entities:
-Hepatic adenoma (true neoplasm, homogeneous GS staining)
-Well-differentiated HCC (malignant hepatocytes)
-Regenerative nodule (in cirrhotic liver)
-Normal liver parenchyma (FNAC sampling)
-Fibrolamellar HCC (young patients, central scar)
-Nodular regenerative hyperplasia.
Distinguishing Features:
-FNH: bile ductules present, Kupffer cells present, heterogeneous GS staining
-Adenoma: no bile ductules, CD34+ sinusoids, homogeneous GS staining
-HCC: cellular atypia, AFP elevation, Glypican-3+
-Normal liver: less cellular, portal tracts present
-Fibrolamellar HCC: oncocytic cells, lamellar fibrosis.
Diagnostic Challenges:
-Distinguishing from hepatic adenoma (major differential)
-Well-differentiated HCC vs FNH
-Normal liver parenchyma in FNAC
-Regenerative nodule in cirrhotic background
-Atypical FNH without central scar
-Multiple FNH vs adenomatosis.
Rare Variants:
-Telangiectatic FNH (prominent vascular spaces)
-Mixed hyperplastic-adenomatous lesion
-Large FNH with mass effect
-Multiple FNH (adenomatosis-like)
-FNH with steatosis
-Inflammatory FNH (increased inflammatory cells).

Sample Pathology Report

Template Format

Sample Pathology Report

Complete Report: This is an example of how the final pathology report should be structured for this condition.

Clinical Information

Patient with liver lesion on imaging, [clinical presentation]

Specimen Adequacy

Adequate for evaluation with high cellularity

Cytomorphological Features

Shows [normal hepatocytes, bile ductules, Kupffer cells] without atypia

Background

Background shows [minimal blood, fibrous tissue fragments]

Imaging Correlation

Imaging shows [central scar, characteristic enhancement pattern]

Differential Diagnosis

Differential includes [hepatic adenoma, well-differentiated HCC, normal liver]

Final Cytological Diagnosis

Benign hepatocytic lesion consistent with Focal Nodular Hyperplasia

Recommendations

Recommend [imaging correlation, clinical follow-up]