Diagnostic Accuracy of USG/CT‐Guided FNAC With Rapid On‐Site Evaluation in Nodular Liver Lesions: Cytology–Histopathology Correlation

M O Jeny; Lekha K Nair

doi:10.1002/dc.70159

. 2026 Jun 15;54(9):680–685. doi: 10.1002/dc.70159

Diagnostic Accuracy of USG/CT‐Guided FNAC With Rapid On‐Site Evaluation in Nodular Liver Lesions: Cytology–Histopathology Correlation

M O Jeny ¹, Lekha K Nair ^2,^✉

PMCID: PMC13428471 PMID: 42294553

ABSTRACT

Introduction

USG/CT‐guided FNACs are a safe, sensitive and specific method to diagnose various liver lesions. Nodular liver lesions have diverse etiologies. FNAC study of liver nodules can help in early diagnosis of various diseases and can also provide material for ancillary techniques if needed.

Methods

Forty‐seven patients who were detected to have nodular liver lesions by USG/CT imaging were chosen and subjected to FNA with ROSE followed by trucut biopsy under USG/CT guidance. This study was done in age group of 30–85 years over a period of 18 months.

Results

Out of 47 cases in cytology, 17 cases (36.17%) were hepatocellular carcinomas, 8 cases (17.02%) were adenocarcinoma metastasis, 2 cases were each of granuloma (4.2%) and liver abscess (4.2%), one case was metastasis from squamous cell carcinoma (2.12%), and 6 cases were poorly differentiated carcinoma (12.7%); 7 cases (14.84%) were inconclusive cytologically, and 4 cases (8.5%) were cytologically negative. FNAC of liver lesions showed sensitivity of 95.10% and a specificity of 83%, positive predictive value was 97.50% and negative predictive value was 71.40%. Overall diagnostic accuracy was 93%. In our study, primary hepatocellular carcinoma is the most common malignancy (36%), followed by metastasis (17%). Females formed the majority of cases (52%) with peak incidence between 61 and 70 years.

Conclusion

USG/CT‐guided FNAC demonstrated high diagnostic accuracy especially when combined with ROSE and good cytology–histopathology concordance in the evaluation of nodular liver lesions.

Keywords: hepatocellular carcinoma, metastatic liver lesions, nodular liver lesions, rapid onsite evaluation (ROSE), USG/CT guided FNAC

1. Introduction

A variety of neoplastic and non‐neoplastic liver lesions can present as liver nodules, and include benign, malignant and inflammatory lesions [1, 2, 3, 4, 5]. Fine needle aspiration is a technique used to study the cells which are obtained by aspiration of cells using a fine needle. Rapid onsite evaluation improves the diagnostic yield in fine needle aspiration cytology [6, 7].

Image‐guided FNAC is a minimally invasive and effective diagnostic procedure for focal liver lesions, offering high sensitivity and accuracy according to many studies. Ultrasonographic or CT guidance can be used for this purpose [8, 9, 10] and is a safe, sensitive and specific method for diagnosis of various liver lesions. Studies have reported a sensitivity between 67% and 100% and accuracy rate as high as 96% in this regard [7, 11, 12, 13, 14].

While most hepatic lesions can be classified reliably on cytomorphology, diagnostic challenges arise in well‐differentiated hepatocellular carcinoma, which may closely mimic benign hepatocytic proliferations, and in poorly differentiated malignant neoplasms, where distinction between primary hepatic tumors and metastatic deposits may be problematic in the absence of another known primary malignancy [15, 16, 17]. With the widespread use of advanced cross‐sectional imaging modalities such as computed tomography and magnetic resonance imaging, incidental detection of hepatic masses has increased. However, radiological features and clinical parameters alone may be insufficient for definitive classification in many cases. Consequently, histopathological examination remains the reference standard for tumor characterization and therapeutic decision‐making, except in lesions with pathognomonic imaging features such as hemangiomas [18, 19].

In this context, the present prospective study was undertaken to evaluate the diagnostic utility of image‐guided FNAC in nodular liver lesions by correlating cytological findings with histopathology. Particular emphasis was placed on assessing sample adequacy using ROSE and determining the overall diagnostic performance of the procedure in routine clinical practice.

2. Methodology

2.1. Study Design and Procedure

This is a hospital‐based study conducted at the Department of Pathology, and approved by the institutional research and ethical committee (Ref.No:11/IEC/21/AIMS‐ 43). Study was conducted over a period of 18 months. Patients with nodular liver lesions detected on ultrasonography or computed tomography and meeting the inclusion criteria were subjected to image‐guided FNAC with ROSE, followed by core (trucut) biopsy for histopathological correlation. All procedures were performed using aseptic precautions with local anesthesia under radiological guidance. Aspirated material was smeared onto glass slides, and selected smears were immediately stained with toluidine blue for ROSE to assess adequacy. Additional smears were wet‐fixed for Papanicolaou staining, and air‐dried smears were prepared for May–Grünwald–Giemsa staining where required. Core biopsy specimens were fixed in formalin and processed for histopathological examination [20].

2.2. Data Collection and Statistical Analysis

Clinical and radiological details were obtained from patient case records. Cytological diagnoses from image‐guided FNAC with ROSE were compared with corresponding histopathological diagnoses from core/trucut biopsy, which was considered the reference standard. For statistical analysis, cytological diagnoses were categorized as malignant or benign/non‐malignant for calculation of diagnostic performance. Inconclusive cytology cases were excluded from sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) calculations but were included when calculating overall diagnostic yield. Sensitivity, specificity, PPV, NPV, and overall diagnostic accuracy were calculated using standard definitions. Diagnostic yield was defined as the proportion of cases in which FNAC provided a definitive cytological diagnosis.

3. Results

This prospective analysis was done on 47 patients, among which 24 were females accounting to 52% of our study population with liver lesions and 23 were males which was 48%. The peak incidence of liver lesions was in the mean age group of 62 years, minimum being 34 years and maximum being 85 years with standard deviation of 10. Among the 47 cases of liver lesions subjected to US guided FNAC, cytological diagnosis in 12 cases were primary hepatocellular carcinoma (high in males), followed by 6 cases of secondary adenocarcinomatous deposits (high in females). Liver abscess was seen in 2 cases, 4 cases were poorly differentiated carcinoma (high in females) and other 7 were benign lesions which was also more in females. Distribution of liver lesions according to cytological findings are given in Figure 1 and the histopathological correlation with cytological findings are provided in Figure 2. FNAC smears showed characteristic cytomorphological features allowing differentiation of HCC (trabecular hepatocytic pattern) from metastatic adenocarcinoma (gland‐forming clusters) (Figure 3).

Distribution of liver lesions—cytology. Pie diagram illustrating the proportional distribution of cytological diagnoses obtained by image‐guided FNAC, showing hepatocellular carcinoma as the most frequent lesion, followed by metastatic adenocarcinoma, poorly differentiated carcinoma, benign lesions, granulomatous lesions, liver abscess, and inconclusive samples. [Color figure can be viewed at wileyonlinelibrary.com]

Comparison of cytology and histopathology diagnoses across hepatic lesion categories. Horizontal bar chart showing category‐wise frequencies identified by cytology and corresponding histopathological examination (HPE). Bar chart depicting the concordance between FNAC‐based cytological diagnoses and corresponding histopathological diagnoses (HPE) across various hepatic lesion categories, including hepatocellular carcinoma, metastatic malignancies, and benign/inflammatory lesion. [Color figure can be viewed at wileyonlinelibrary.com]

FNAC smears of malignant liver lesions (PAP stain, 400×). [Color figure can be viewed at wileyonlinelibrary.com]

4. Discussion

The present study demonstrates that image‐guided FNAC with ROSE is a useful and minimally invasive diagnostic approach for the evaluation of nodular liver lesions. In our series, FNAC showed high sensitivity (95.10%), specificity (83%), PPV (97.5%), and overall diagnostic accuracy (93%) when correlated with histopathology. These findings support the value of FNAC as a reliable first‐line diagnostic tool, particularly in the evaluation of malignant hepatic lesions. Nasir et al., reported the mean age at presentation as 12–55 years with male to female ratio of 1.7:1 [21]. In contrast, our study showed a near‐equal gender distribution (male: female = 1:1.08). Nazir et al. reported that among 100 cases, 81 were malignant, including 49 cases of HCC and 32 metastatic tumors. In our study of 47 cases, HCC was the most frequent malignant lesion, followed by metastatic adenocarcinoma. Swamy et al. in their study observed a wide age range of patients from 8 months to 90 years with a male predominance and the male to female ratio was 2:1 [22]. In contrast, the age group we observed in our study ranges from 30 to 85 years. Peak incidence of liver lesions in their study was in the age group of 60–70years and that too in‐ females. Also, the study reported HCC in 36.12% and metastatic adenocarcinoma in 19.45% of cases, which aligns with our findings, although our study showed a higher proportion of HCC.

Study by Mahla et al. 2022 done in 60 patients, showed liver lesions in age group of 31–90 years which is similar to our study and male to female ratio was 4.2: 1 [23]. Out of 60 patients in their study, 39.62% of cases were HCC and 39.12% of cases were adenocarcinoma, 11.32% cases were poorly differentiated carcinoma and 5 cases were inconclusive. Similar to our study Asghar et al. had 32 cases, 6 of which were diagnosed as benign, 18 as malignant; moreover, out of 18 cases, 10 cases were HCC, 6 cases were adenocarcinoma metastasis and 2 cases were melanoma metastasis, and 8 were non‐neoplastic inflammatory lesions [24]. In contrast, although we observed a similar predominance of HCC (17) and metastatic adenocarcinoma (8), no melanoma cases were encountered in our study.

Bakshi et al. studied 20 cases of liver lesions, 7 cases were hepatoblastoma, 4 cases were hepatocellular carcinoma, 6 cases were metastases, eight cases were abscess and one case each were of hydatid cyst and tuberculosis. We did not encounter hydatid cyst or tuberculosis likely due to differences in patient demographics and referral patterns [25]. Various studies such as those by McGahan et al. [26] and Balani et al. [27], reported metastatic lesions as the most common liver malignancies. However, in our study, primary hepatocellular carcinoma constituted the majority of malignant lesions. This variation may reflect regional differences in prevalence of risk factors such as chronic hepatitis, alcohol‐related liver disease, and cirrhosis.

Reddy et al. [19] studied 755 cases, 524 patients had metastases to liver, 148 patients had hepatocellular carcinoma, 14 cases were benign neoplasms and 53 were non neoplastic conditions [28]. Rastogi et al. 2019 reported a diverse spectrum of liver lesions, including benign, inflammatory, and metastatic tumors [29]. In their study among the 57 cases, there were cirrhosis with hepatic granuloma (3 cases), pyogenic abscess (3 cases), hepatic adenoma (2 cases), focal nodular hyperplasia (2 cases), hepatoblastoma (1 case), hepatocellular carcinoma (17 cases), adenocarcinoma deposits (20 cases), deposits from small cell carcinoma (3 cases), deposits from ductal carcinoma breast (2 cases), and one case each of deposits of squamous cell carcinoma, non‐Hodgkin's lymphoma, neuroendocrine tumor, and adeno‐squamous carcinoma. Although our study identified a case of squamous cell carcinoma metastasis, we did not encounter rarer entities such as hepatic adenoma, focal nodular hyperplasia, or lymphoma.

Several studies have demonstrated a strong correlation between cytological and histopathological diagnoses in hepatic lesions. Balani et al. [27], Agarwal et al. [30], and Rastogi et al. 2019 [29] demonstrated the accuracy of FNAC in assessing liver masses by reporting a high concordance between cytological results and the histological diagnosis. Selhi et al. [31] reported a diagnostic yield of 86.25% during 2011–2013, which improved to 95.8% during 2015–2016, reflecting advancements in sampling techniques and interpretation. Comparison of results and observation with standard studies is shown in Table 1. In concordance with these findings, our study achieved a diagnostic yield of 97%, further emphasizing the effectiveness of USG‐guided FNAC as a reliable, minimally invasive diagnostic tool for liver lesions.

TABLE 1.

Comparison of diagnostic performance of FNAC for hepatic lesions with published studies.

Study	Cases (n)	Inconclusive (%)	HCC (%)	Metastasis (%)	Sensitivity (%)	Specificity (%)	Accuracy (%)	PPV (%)	NPV (%)	Diagnostic yield (%)
Our Study	47	14.9	36.0	17.0	95.10	83.0	93.0	97.5	71.4	97.0
Nazir et al. (2010)	100	19.0	60.49	39.51	95.2	100	96.0	NR	NR	NR
Swamy et al. (2011)	72	1.38	36.12	30.56	96.87	100	97.82	100	93.34	98.61
Mahla et al. (2022)	60	8.3	39.62	39.12	NR	NR	NR	NR	NR	NR

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Note: Comparison of sample size, proportion of inconclusive cases, and relative frequencies, sensitivity, specificity, accuracy, PPV, NPV and diagnostic yield between the present study and previously published series.

Abbreviation: NR = Not reported.

In our study, malignant lesions were more likely diagnosed with cytology compared to benign lesions. ROSE helped to assess the cellularity in most of the liver lesions. Our investigation revealed a greater prevalence of hepatocellular carcinoma, despite the majority of reported studies demonstrating metastasis as the most frequent hepatic lesion. This could be explained by the rising incidence of HCC in the area under study and the exclusion of known metastatic cases where clinical, radiological, and serological findings were already confirmatory, which reduced the sampling of obvious secondary deposits.

A key strength of the present study is the incorporation of rapid on‐site evaluation (ROSE), which enabled immediate assessment of smear adequacy during the procedure. This is particularly relevant in hepatic lesions, where necrosis, hemorrhage, fibrosis, or low cellularity may compromise cytological interpretation. In our series, ROSE likely contributed to improved sample adequacy and timely recognition of inadequate aspirates, allowing repeat sampling when required. However, as the present study did not include a control group without ROSE, our findings can be interpreted as demonstrating the practical utility of ROSE in routine diagnostic workflow rather than proving superiority over conventional FNAC alone. The present study has certain limitations. It was conducted at a single center with a relatively small sample size, which may limit generalizability. In addition, although ROSE was incorporated into the diagnostic workflow, the study did not include a comparison arm without ROSE. Therefore, the present findings cannot establish a direct incremental benefit of ROSE over conventional image‐guided FNAC alone. Larger comparative studies are needed to further define the specific contribution of ROSE to diagnostic performance in hepatic lesions.

5. Conclusion

USG/CT‐guided FNAC is a safe, rapid, and effective diagnostic modality for the evaluation of nodular liver lesions, showing high sensitivity, specificity, and cytology–histopathology concordance in the present study. Hepatocellular carcinoma was the most common malignant lesion encountered, followed by metastatic adenocarcinoma. The use of ROSE was helpful for immediate assessment of smear adequacy during the procedure and may support diagnostic confidence in routine practice. However, larger comparative studies are needed to determine the independent incremental benefit of ROSE over conventional image‐guided FNAC.

Author Contributions

M.O.J.: conceptualization, data collection, investigation, methodology, writing – original draft. L.K.N.: supervision, study design, histopathological review, validation, writing – review and editing. Both authors approved the final manuscript.

Funding

The authors have nothing to report.

Ethics Statement

The study protocol was approved by the Institutional Ethics Committee and informed consent was obtained from all participants prior to inclusion in the study.

Conflicts of Interest

The authors declare no conflicts of interest.

Acknowledgments

The authors acknowledge the technical assistance of the Department of Pathology, Amala Institute of Medical Sciences, Thrissur for their support in specimen processing and data retrieval. The authors acknowledge Dr. Sneha Das and “IMPACT”, a research support program by Amala Integrated Medical Research Department (AIMRD), Amala Institute of Medical Sciences, Thrissur, for providing publication support.

Data Availability Statement

The datasets generated and analysed during the current study are available from the corresponding author upon reasonable request.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Data Availability Statement

The datasets generated and analysed during the current study are available from the corresponding author upon reasonable request.

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[dc70159-bib-0006] 6. Walia S., Aron M., Hu E., and Chopra S., “Utility of Rapid On‐Site Evaluation for Needle Core Biopsies and Fine‐Needle Aspiration Cytology Done for Diagnosis of Mass Lesions of the Liver,” Journal of the American Society of Cytopathology 8, no. 2 (2019): 69–77. [DOI] [PubMed] [Google Scholar]

[dc70159-bib-0007] 7. Ciliberti V., Maffei E., D'Ardia A., et al., “Combined Fine Needle Aspiration Cytology and Core Needle Biopsy in the Same Setting: A Two‐Years' Experience,” Cytopathology 35, no. 1 (2024): 78–91. [DOI] [PubMed] [Google Scholar]

[dc70159-bib-0008] 8.“Image Guided Fine Needle Aspiration Cytology Study of Liver Lesions,” Vascular and Endovascular Review 8, no. 9s (2025): 73–78, https://verjournal.com/index.php/ver/article/view/721. [Google Scholar]

[dc70159-bib-0009] 9. Bajantri S. R., Mehta D. P., Shah P. C., and Patel R. A., “Ultrasound Guided Fine Needle Aspiration Cytology in Deep Seated Lesions: An Effective Diagnostic Tool,” International Journal of Research in Medical Sciences 10, no. 12 (2022): 2800. [Google Scholar]

[dc70159-bib-0010] 10. Bayrak B. Y. and Paksoy N., “Diagnostic Accuracy of Fine‐Needle Aspiration Cytology for Extrathyroidal Head‐And‐Neck Lesions Performed by a Cytopathologist With the Assistance of Radiologist: A Single‐Center Study,” CytoJournal 22, no. 57 (2025). [DOI] [PMC free article] [PubMed] [Google Scholar]

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[dc70159-bib-0012] 12. Maru P., Vyas V. R., Rai V., Kapoor S., and Satarupa S., “Investigating the Sensitivity and Specificity of Fine Needle Aspiration Cytology for Diagnosing Malignant Liver Tumors,” Journal of Medical Sciences 11, no. 1 (2025): 8–14. [Google Scholar]

[dc70159-bib-0013] 13. Elbanna K. Y. and Kielar A. Z., “Computed Tomography Versus Magnetic Resonance Imaging for Hepatic Lesion Characterization/Diagnosis,” Clinics in Liver Disease 17, no. 3 (2021): 159–164. [DOI] [PMC free article] [PubMed] [Google Scholar]

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PERMALINK

Diagnostic Accuracy of USG/CT‐Guided FNAC With Rapid On‐Site Evaluation in Nodular Liver Lesions: Cytology–Histopathology Correlation

M O Jeny

Lekha K Nair