International Journal of Medical and Pharmaceutical Research
2026, Volume-7, Issue 1 : 1404-1410
Research Article
Study of Fine Needle Aspiration Cytology of Salivary Gland Lesions According to the Milan System with Histopathological Correlation – A Prospective Study
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1
3rd year Resident, Department of Pathology, PDU Medical College and Hospital, Rajkot, India
2
Associate Professor, Department of Pathology, PDU Medical College and Hospital, Rajkot, India
3
Assistant Professor, Department of Pathology, PDU Medical College and Hospital, Rajkot, India
4
Professor and Head, Department of Pathology, PDU Medical College and Hospital, Rajkot, India
Received
Jan. 8, 2026
Accepted
Feb. 4, 2026
Published
Feb. 8, 2026
Abstract

Introduction: Salivary gland lesions are commonly encountered in clinical practice. Fine Needle Aspiration Cytology (FNAC) is a reliable, minimally invasive, and cost-effective diagnostic tool with high specificity and sensitivity. The Milan System for Reporting Salivary Gland Cytopathology (MSRSGC) provides a standardized, evidence-based framework for accurate diagnosis and management of these lesions. We have undertaken this study for evaluation of salivary gland lesions by this newly introduced grading system for predicting the malignant potential of these lesions.

Materials and Methods: The present study was carried out in cytopathology and histopathology laboratory of department of pathology, PDU Medical College and Hospital, Rajkot during the 1st August 2024 to 31st July 2025. All the cases referred to the department of Pathology from the Department of Surgery, ENT, and Dental Surgery for evaluation of salivary gland lesions were included in the study. FNAC is a diagnostic tool in which cells are extracted from a palpable swelling using 23-24G needle with disposable syringes and smears are prepared and stained with H&E, MGG and Papanicolauou stain whenever it was required. All the cases were categories according to MSRSGC. and available histopathology reports were used for correlation.

Result: We have received 94 salivary gland lesions for aspiration over a period of 1 year. The most affected age group was from 21 to 35 years. Most of the study subjects were presented with parotid swellings (75%) followed by submandibular gland (23%). As per the MSRSGC classification system, 26 cases were categorized as non-neoplastic while 68 as neoplastic lesions. Of the non-neoplastic cases, 02(3%) were grouped in category I, 24 (24%) in category II. Out of the 68 salivary gland neoplasms, 49(52%) cases were in category IVa and 7(8%) cases in category IVb 3(4%) cases in category V, and 9(9%) cases in category VI. Out of total 94 cases, 36 patients were correlated with histopathological findings. The sensitivity of FNAC was 75% and specificity was 100%.

Conclusion: FNAC, when interpreted using the MSRSGC, provides a reliable and standardized method for diagnosing salivary gland lesions. The Milan System improves diagnostic accuracy, facilitates appropriate clinical management, and helps predict malignancy risk. Correlation with histopathology confirms FNAC as an excellent initial diagnostic tool, particularly for distinguishing benign from malignant salivary gland lesions

Keywords
INTRODUCTION

Salivary gland lesions encompass a wide range of non-neoplastic and neoplastic entities with diverse histomorphological features. Accurate preoperative diagnosis is crucial for planning the appropriate surgical approach and management. Fine Needle Aspiration Cytology (FNAC) has become the preferred initial diagnostic procedure for evaluating salivary gland swellings due to its simplicity, minimal invasiveness, and rapid turnaround time¹.

 

However, diagnostic terminology and reporting criteria have historically varied across institutions, resulting in inconsistent interpretations and reporting². To address this, the Milan System for Reporting Salivary Gland Cytopathology (MSRSGC) was introduced, providing a standardized reporting structure with defined diagnostic categories and associated risk of malignancy (ROM).

 

This study aims to evaluate the cytomorphological features of salivary gland lesions according to the MSRSGC, and to correlate cytological diagnoses with histopathological findings wherever available

MATERIALS AND METHODS

Study Design and Duration

A prospective observational study was conducted in the Cytopathology and Histopathology Laboratory, Department of Pathology, P.D.U Medical College and Hospital, Rajkot, Gujarat over a period of one year, involving 94 patients presenting with salivary gland swellings. All the cases referred to the department of Pathology from the Department of Surgery, ENT, and Dental Surgery for evaluation of salivary gland lesions were included in the study.

 

Procedure

FNAC was performed using a 22–24 gauge needle, with 10 mL syringe. Both air-dried and alcohol-fixed smears were prepared and stained using:

  • Hematoxylin and Eosin (H&E)
  • May-Grünwald Giemsa (MGG)
  • Papanicolaou (PAP)

 

Categorization

Each case was classified according to the Milan System for Reporting Salivary Gland Cytopathology (MSRSGC) into one of the following categories:

  1. Category I: Non-diagnostic / Unsatisfactory
  2. Category II: Non-neoplastic
  3. Category III: Atypia of undetermined significance (AUS)
  4. Category IVa: Benign neoplasm
  5. Category IVb: Salivary gland neoplasm of uncertain malignant potential (SUMP)
  6. Category V: Suspicious for malignancy
  7. Category VI: Malignant

 

Histopathological Correlation

Surgical excision or biopsy specimens were available for 36 cases, which were compared with their corresponding cytological diagnosis to determine diagnostic accuracy.

 

Statistical Analysis

Sensitivity, specificity, and diagnostic accuracy were calculated using standard formulas

RESULTS

Distribution of cases according to sex, age, and site of involvement of the lesion.

 

Table 1: - SEX DISTRIBUTION OF PATIENTS

                             SEX

                                 CASES

                          PERCENTAGE

MALE

58

62%

FEMALE

36

38%

TOTAL

94

100%

 

A male predominance was observed (male-to-female ratio 1.8:1), consistent with previous studies⁴⁻⁶.

 

Table 2: - AGE WISE DISTRIBUTION OF SALIVARY GLAND LESION

AGE RANGE

CASES

PERCENTAGE

0-20

04

4%

21-35

39

42%

35-50

23

24%

51-65

18

19%

>65

10

11%

TOTAL

94

100%

 

In our study we had male predominance and most of the cases were seen in the age group of 21-35 years.

 

Table 3: - SITE DISTRIBUTION OF SALIVARY GLAND LESION

SITE

CASES

PERCENTAGE

PAROTID GLAND

71

75%

SUBMANDIBULAR GLAND

22

23%

MINOR SALIVARY GLAND

01

2%

TOTAL

94

100%

 

Patients had presented with lesions in all the major and minor salivary glands-parotid, submandibular and sublingual. The parotid gland was the most commonly affected site, aligning with findings in prior studies⁷⁻⁹.

 

Table 4: - CYTOLOGICAL EVALUTION WAS DONE ACCORDING TO THE MILAN SYSTEM.

CATEGORY

CYTOLOGICAL DIAGNOSIS AND NO. OF CASES

PERCENTAGE

Category I: Non-diagnostic (ND)

Only hemorrhagic material aspirate (02)

3%

Category II: Non-neoplastic (NN)

Chronic sialadenitis (17), Acute on chronic sialadenitis (04),

Acute on chronic parotitis (02),

Autoimmune sialadenitis (01)

24%

Category III: Atypia of undetermined significance (AUS)

00

0%

Category IVa: Neoplasm: Benign (NB)

Pleomorphic adenoma (35), Warthin’s tumor (14)

52%

Category IVb: Neoplasm: Salivary gland neoplasm of uncertain malignant potential (SUMP)

Basal cell adenoma (07)

 

8%

Category V: Suspicious of malignancy (SM)

Mixed tumor with necrosis (02)

Suspicious of adenoid cystic carcinoma (01)

4%

Category VI: Malignant (M).

Mucoepidermoid carcinoma (06)

Adenoid cystic carcinoma (03)

9%

TOTAL

94

100%

Overall, 26 (27%) cases were non-neoplastic, and 68 (73%) were neoplastic. Pleomorphic adenoma was the most common lesion, followed by Warthin’s tumor.

 

Histopathological Correlation (n = 36)

Out of the 36 cases available for histopathology:

Diagnosis cytology

Malignant on histology

Non neoplastic on histology

Benign on histology

Total

Malignant

09

00

00

09

Non neoplastic

00

22

02

24

Benign

03

03

55

61

Total

12

25

57

94

 

Parameter

Result

Sensitivity

75%

Specificity

100%

Diagnostic Accuracy

86%

 

 

DISCUSSION

The findings of this study reaffirm that FNAC is a highly specific, minimally invasive, and cost-effective diagnostic tool for evaluating salivary gland lesions¹⁰⁻¹². The age and site distribution pattern observed aligns with previous studies, showing a predominance of parotid involvement and peak incidence in young to middle-aged adults.

 

The distribution of lesions in this study parallels prior research, with parotid involvement being the most common and pleomorphic adenoma the predominant benign tumor⁴,⁶,⁸. The observed sensitivity (75%) and specificity (100%) correspond with results reported by Manju et al., Sheetal et al., and Yogambal et al.¹³⁻¹⁵. Although certain low-grade or cystic malignancies may yield false-negative results, false positives are rare, confirming FNAC’s reliability for surgical decision-making.

 

The Milan System standardizes salivary gland cytology reporting and bridges the diagnostic gap between cytopathologists and clinicians³,¹⁶. Its category-wise ROM assists in management planning, as summarized below:

  • Category II: Conservative management
  • Category IVa: Simple excision
  • Category VI: Radical surgery or oncological therapy

Overall, the present findings closely align with previous Indian and international studies, demonstrating the effectiveness of MSRSGC in routine reporting and its clinical utility in guiding management.

 

 

 

 

 

Comparison of Risk of Malignancy (ROM) with Other Studies

MSRSGC Category

ROM (Present Study)

Faquin et al., 2018³

Rossi et al., 2017⁹

Baloch et al., 2018¹⁰

Manju et al., 2018¹³

I – Non-diagnostic

0%

25%

29%

25%

20%

II – Non-neoplastic

0%

10%

10%

10%

8%

III – AUS

20%

30%

29%

22%

IVa – Benign neoplasm

6%

5%

4%

4%

6%

IVb – SUMP

15%

35%

37%

38%

33%

V – Suspicious for malignancy

66%

60%

65%

69%

60%

VI – Malignant

100%

90%

96%

98%

92%

The ROM values in the present study are largely consistent with the established Milan System benchmarks. The slightly lower ROM in the SUMP and Suspicious for malignancy categories may be attributed to the smaller number of histologically correlated cases.

CONCLUSION

FNAC of salivary gland lesions, when interpreted using the Milan System for Reporting Salivary Gland Cytopathology, is an effective and reliable diagnostic modality with high specificity and good sensitivity.
The system enhances diagnostic clarity, risk stratification, and clinical decision-making. Histopathological correlation further validates the diagnostic reliability of FNAC, especially in differentiating benign from malignant lesions

REFERENCES
  1. Orell SR, Sterrett GF, Whitaker D. Fine Needle Aspiration Cytology. 5th ed. Philadelphia: Churchill Livingstone Elsevier; 2012.
  2. Seethala RR, LiVolsi VA, Baloch ZW. Relative accuracy of fine needle aspiration and frozen section in the diagnosis of salivary gland lesions. Head Neck. 2005;27(3):217–223.
  3. Faquin WC, Rossi ED, Baloch Z, et al. The Milan System for Reporting Salivary Gland Cytopathology. Springer International Publishing; 2018.
  4. Kala C, Kala S, Khan L. FNAC of salivary gland lesions: A study of 400 cases. J Clin Diagn Res. 2014;8(12):FC01–FC04.
  5. Sonal B, Dhananjay P, Anjali P. Cytological study of salivary gland lesions: Experience from a tertiary care hospital. Int J Res Med Sci. 2016;4(12):5165–5169.
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  9. Rossi ED, Wong LQ, Bizzarro T, et al. The Milan System for Reporting Salivary Gland Cytopathology: An international multi-institutional study. Cancer Cytopathol. 2017;125(10):757–766.
  10. Baloch ZW, Faquin WC, Layfield LJ, et al. The Milan System for Reporting Salivary Gland Cytopathology: Analysis and suggestions of initial review. Diagn Cytopathol. 2018;46(9):751–759.
  11. Layfield LJ, Glasgow BJ. Diagnosis of salivary gland tumors by fine needle aspiration cytology: A review of clinical utility and pitfalls. Diagn Cytopathol. 1991;7(3):267–272.
  12. Kini SR. Guides to Clinical Aspiration Biopsy: Salivary Glands. New York: Igaku-Shoin; 1996.
  13. Manju M, Kumar H, Bhatia A. Diagnostic accuracy of FNAC in salivary gland lesions with histopathological correlation. Ann Pathol Lab Med. 2018;5(7):A588–A592.
  14. Sheetal S, Chandanwale SS, Annasaheb L, et al. Diagnostic utility of FNAC in salivary gland lesions using Milan system. Int J Health Sci Res. 2019;9(3):17–24.
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  16. Rossi ED, Faquin WC. The Milan System for Reporting Salivary Gland Cytopathology (MSRSGC): An evidence-based classification with management recommendations. Cancer Cytopathol. 2018;126(6):394–404.
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