European Journal of Cardiovascular Medicine

Diagnosing salivary gland lesions through cytological techniques remains a complex endeavor in contemporary pathology. This diagnostic challenge stems from the wide morphological diversity inherent in salivary gland neoplasms, the continual incorporation of novel entities in successive editions of the World Health Organization (WHO) tumor classification, and the presence of significant intratumoral heterogeneity [1,2]. Moreover, substantial cytological overlap between benign and malignant lesions frequently complicates accurate differentiation and definitive diagnosis [3].

Fine-needle aspiration cytology (FNAC) has emerged as a widely utilized first-line diagnostic tool for salivary gland swellings due to its safety profile, minimally invasive nature, and cost-effectiveness. It plays a pivotal role in distinguishing benign from malignant pathologies preoperatively and often provides a preliminary indication of the tumor subtype [4,5]. This is particularly advantageous in avoiding unnecessary surgical interventions for non-neoplastic or benign conditions, especially in elderly patients or those with significant comorbidities [6]. Numerous studies have reported favorable diagnostic metrics for FNAC, with sensitivity values ranging from 87% to 100% and specificity between 92.8% and 93.9% [7–9]. Nevertheless, the accuracy of FNAC is highly contingent upon the quality of the specimen obtained and the interpretive acumen of the reporting cytopathologist [10].

Despite its utility, FNAC is not without limitations. Sampling inadequacies, especially in cystic lesions such as Warthin’s tumor and low-grade mucoepidermoid carcinoma, frequently lead to false-negative results [11]. Furthermore, interpretative challenges—such as misclassifying reactive or metaplastic changes as malignant features—can contribute to both false-positive and false-negative diagnoses [12]. These diagnostic pitfalls underscore the need for a more structured, standardized framework for reporting salivary gland cytology.

The present study was undertaken to assess the diagnostic performance of FNAC in salivary gland lesions over a two-year period at our institution. A cytohistological correlation was performed, with special attention paid to discordant cases to identify common sources of diagnostic error and to explore opportunities for enhancing the reliability and accuracy of cytopathological evaluation.

Study Design and Setting

This was a retrospective study conducted in the Department of Pathology, Government Medical College, Srikakulam.

Duration: The study spanned between 1/1/2023 and 31/12/2024 at Government Medical College, Srikakulam.

Sample Size

Sample size was calculated using formula: = z² x p(1-p)/ d2

z= Confidence level(95%)

d= margin of error(5.5)

p= prevalence based on previous study(0.3)

By this formula, sample size calculated is 63.

A total of  81 patients were included 24 months. Sample size was determined based on previously reported sensitivity values for FNAC in malignant salivary gland lesions.

Inclusion Criteria

• Patients of all age groups and both genders.
• All patients who underwent pre-operative FNAC of salivary gland lesions and were diagnosed with malignant neoplasms.
• Patients who subsequently underwent surgical excision and histopathological examination.
• Both direct and ultrasound-guided FNAC cases.
• Patients presenting with major or minor salivary gland swellings, including intraoral lesions.

Exclusion Criteria

• Patients with recurrent salivary gland lesions.
• Patients who did not undergo surgical excision or had incomplete follow-up data.
• Cases already under treatment for salivary gland lesions.

Data Collection and Slide Review

• Data was obtained retrospectively from medical records.
• FNAC procedures were conducted using 22–24 gauge needles and 5 ml syringes.
• Smears were stained using Hematoxylin & Eosin (H&E).
• Histopathological specimens were fixed in 10% formalin, processed, and stained with H&E.

A total of 93 patients who presented with salivary gland lesion underwent FNAC for further evaluation at a tertiary centre of Government General Hospital, Srikakulam. The basic characteristics of the patient are mentioned below [Table 1.].

The majority of the patients belonged to age group of 31yrs to 40 yrs(37.63%). The mean age was 35.42. Age wise distribution depicted in [Figure 1]. Males are more commonly involved of ratio 1.26:1. Parotid glands were most commonly involved with 67 cases(72.04%) followed by the submandibular gland swelling involving 24 cases(25.80%) and least amount of cases are seen with minor salivary glands involving 2 cases(2.15%). The various diagnosis of salivary gland lesions in GGH, Srikakulam were tabulated below [Table 2.].

Figure 1.

Out of 93 cases for FNAC of salivary gland lesion, 39 cases(41.93%) were Non- neoplastic, 40 cases(43.01%) were Benign neoplasms and 14 cases(15.05 %) were Malignant neoplasms [Figure 2.].

Figure 2.

Out of the 93 cases that came for FNAC evaluation, 44 cases came for Histopathological examination and thus a cytohistopathological correlation was seen in 47.31% of cases(6.81%).

Forty for cases were available for histopathological correlation. Out of which, discordance were observed in 3 cases. Out of 4 cases that were given as suspicious of malignancy in FNAC, 3 cases were diagnosed as Pleomorphic adenoma on HPE and one case was diagnosed as Low grade Mucoepidermod carcinoma. [Figure 3a,b,c,d.].

Out of 24 cases that were diagnosed as Sialadenitis in FNAC, 4 cases were diagnosed as Sialadenitis in HPE. Out of 2 cases that were diagnosed as Lymphoproliferative disorder in FNAC, 2 cases were diagnosed as Lymphoproliferative disorder in HPE. Out of 4 cases that were diagnosed as Cytic lesions (Retention cysts) in FNAC, 2 cases were diagnosed as Retention cysts in HPE. Out of 36 cases that were diagnosed as Pleomorphic adenoma in FNAC, 24 cases were diagnosed as Pleomorphic adenoma in HPE. Out of 4 cases that were diagnosed as Warthin’s tumor in FNAC, 3 cases were diagnosed as Warthin’s tumor in HPE. Out of 8 cases that were diagnosed as Mucoepidermoid carcinoma in FNAC, 6 cases were diagnosed as Mucoepidermoid carcinoma in HPE. Out of 2 cases that were diagnosed as High grade (salivary duct) tumor in FNAC, 1 case was diagnosed as Salivary duct tumor in HPE.

Table 1: Clinicopathological profile of salivary gland lesion patients that underwent FNAC.

Table 2: FNAC diagnosis of Salivary gland lesions.

Fine-needle aspiration cytology (FNAC) is a rapid, cost-effective, minimally invasive diagnostic modality that serves as an efficient outpatient triage technique for evaluating salivary gland lesions. With negligible risk of iatrogenic infection and tumor seeding, FNAC facilitates preoperative stratification and can obviate unnecessary surgical interventions in approximately one-third of patients [10]. It has an edge over frozen sections because it proves the nature of the lesion before surgery and thus acts as a useful triage tool and prevents patients with non-neoplastic lesions from undergoing surgery[16].

Benign salivary aspirates constituted a significant number of the cases in this study, as stated in a previous study by Rajwanshi et al[17].

A wrong judgment about the tumor location or inappropriate positioning of the needle by the person performing FNA may lead to a sampling error. The nature of the lesion may also be a contributing factor because hemorrhagic or cystic fluid within the lesion and fibrosis of the lesion may lead to a nondiagnostic or false-negative aspirate[18,19,20].

In the present study, the mean age of patients was 35.42 years, aligning with Legaspi et al. [13] who identified the 21–40-year age group as the most frequently affected demographic (38.16%).

Gender distribution in our study demonstrated a male predominance (55.91%), with a male-to-female ratio of approximately 1.26:1. This contrasts with findings from Park et al. [9] and Legaspi et al. [13] who reported female predominance and near male preponderance, respectively. The parotid gland was the most commonly involved site (72.04%) in our study, consistent with previous literature by Park et al. [9] (81.1%), Legaspi et al. [13] (78.95%), and Rohilla et al. [12] (61.3%).

Diagnostic discrepancies were noted in three cases. Three cases of pleomorphic adenoma displaying mild pleomorphism and squamous metaplasia were overcalled as suspicious of malignancy.

The overall diagnostic performance of FNAC in this study demonstrated a sensitivity of 66.7%, specificity of 95.2%, positive predictive value (PPV) of 80%, and negative predictive value (NPV) of 90.9%. These metrics are consistent with those reported by Gaikwad et al. [14], Kala et al. [11], Rohilla et al. [12], and Pujani et al. [10].

Our institutional findings reaffirm the applicability and diagnostic reliability of FNAC, which facilitated clearer interpretive communication and aided in the formulation of tailored therapeutic plans. FNAC remains invaluable in distinguishing benign from malignant salivary gland lesions. Nevertheless, for cystic neoplasms where aspirates are frequently paucicellular or unrepresentative, image-guided FNAC via ultrasonography or computed tomography is advisable to enhance diagnostic yield and reduce false-negative interpretations.

To ensure accurate cytopathologic assessment, continuous professional development in FNAC interpretation remains crucial, especially in distinguishing cellular subtleties across neoplastic spectrums [15].

Limitations of this retrospective analysis include inherent selection bias—limited to cases that underwent surgical excision—absence of cell block evaluation, and restricted sample size from a single-center experience.

Acknowledgements
The authors express their sincere gratitude to the Head of the Department: Dr. I. Vijaya Bharathi mam and the Department of Pathology, Government Medical College, Srikakulam for their unwavering support.

In conclusion, when performed with adequate sampling and interpreted by experienced cytopathologists, fine-needle aspiration cytology(FNAC) serves as a highly reliable diagnostic modality for the majority of salivary gland lesions. In instances of non-diagnostic or equivocal cytology, adjunctive modalities such as ultrasonography, computed tomography, or flow cytometry can enhance diagnostic accuracy. Furthermore, FNA-derived smears offer the advantage of being amenable to ancillary investigations, including special staining techniques and immunocytochemical analysis.

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