One in four women will experience breast disease at some point in their lives. For many years, fine needle aspiration cytology (FNAC) has been the predominant technique used for the pathological diagnosis of breast lumps, particularly in distinguishing between benign and malignant conditions1

Breast cancer ranks as one of the primary causes of cancer-related deaths among women, yet early detection can significantly improve survival rates. Most breast lesions are benign and often receive less focus than malignant ones. However, certain benign lesions have the potential to develop into malignant forms later in life. Therefore, it is crucial to thoroughly examine and understand these lesions to identify high-risk patients and ensure they receive regular monitoring2

Triple assessment, is a term applied for the stratified approach to a breast lump which includes clinical examination, imaging (mammography or ultra sonogram) and cytology (FNAC or Core Needle Biopsy). Triple assessment (TA) has evolved as a method of diagnosing the disease process in a breast lump3.In recent years, both FNAC and core needle biopsy (CNB) have proven to be highly effective in the diagnostic evaluation of palpable breast lumps.

Fine needle aspiration cytology (FNAC) is utilized as a pre-operative assessment for breast lumps. This method is cost-effective and helps avoid unnecessary surgical procedures. The increased reliability of FNAC in identifying malignancies has led to an approximately 80% reduction in the use of frozen-section histology4.The introduction of the Tru-Cut biopsy (TCB) in recent years has significantly enhanced histological evaluations, providing crucial information necessary for developing appropriate treatment plans for patients. It has become the preferred method for diagnosing breast lesions before surgical intervention5

Aims & Objectives

1. The primary aim of this study is to compare the diagnostic efficacy of FNAC and tru-cut biopsy in the evaluation of a clinically palpable breast lump.
2. To compare the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of FNAC with those of tru-cut biopsy.

This study is a prospective comparative study aimed at evaluating the diagnostic efficacy of FNAC versus Tru-cut in clinically palpable breast lump. The study was conducted in the Department of general Surgery at a tertiary care centre of South Gujarat over a period of 18 months.

Inclusion Criteria

1. Patients having clinically palpable breast lump and giving consent for FNAC or Tru-cut biopsy investigation and willing for surgical management.

Exclusion Criteria

1. Infective etiology (Breast abscess, tuberculosis)
2. Traumatic necrosis

Sample size: We achieved sample size of 150 for this study.

Data collection: A random sampling method was used. Patients were divided in two groups (75 in each group) based on Odd even numbering method. Odd-number patients underwent FNAC for diagnosing breast lump and even number patients underwent Tru-cut biopsy for diagnosing breast lump. All patients underwent surgical management. Post surgery lump’s Histopathological examination report was collected and considered gold standard then it was compared with pre-operative FNAC/ Tru-cut biopsy report whichever was performed.

Ethical considerations:

Informed consent was obtained from all patients.

Confidentiality of patient data was maintained throughout the study.

Out of 150 female studied age incidence ranged from 11 year to 82 year. Most common age group having breast lump was 21-30 years. Commonest age group for benign lesion was 21-30 and for malignant lesion was 31-40. Most common benign lesion was Fibroadenoma & malignant lesion was Invasive ductal carcinoma. Sensitivity, specificity, PPV, NPV of FNAC was 81.25%, 98.30%, 92.85%, 95.08% respectively and for TRUCUT biopsy was 96.29%, 100%,100%, 97.95% respectively. Diagnostic accuracy of FNAC was 91.87% & for Tru cut was 98.56%.

Table 1- calculation of diagnostic efficacy of FNAC

Table 2- Calculation of diagnostic efficacy of tru-cut

Table 3- Comparison of diagnostic efficacy of FNAC and Tru-cut biopsy

Kalyani Tripathi et al.’s study6 (Lucknow,2022) shows that out of 42 patients with suspect of breast cancer majority of the patients in the study (78.6%) were in the age group of 31-50 years which is similar to our study.

Manisha Sharma et al.’s study7(Amritsar,2017) sensitivity and specificity of FNAC was 92.15% and 96.5% respectively. Positive predictive value was 97.9% while negative predictive value was 87.5% for FNAC. Siddique, Rizia et al.’s study8 (Kolkata,2015-2016) FNAC has sensitivity 94.3%, specificity 100%, PPV 100%, NPV 87.9%, diagnostic efficiency 95% while NCB has sensitivity 97.3%, specificity 100%, PPV 100%, NPV 81.8% and diagnostic accuracy 97.6% in diagnosing breast lumps. S.M. Hossain et al.'s9 study’s study sensitivity and specificity of FNAC was 81.25% & 98.3% respectively and for Trucut was 65% &100% respectively. Sharang S Kulkarni et al’s10 study sensitivity and specificity of FNAC was 92.8% & 100% respectively and for Trucut was 92% &100% respectively. All 4 studies were similar to our study result.

In our research, Tru-cut biopsy’s accuracy level has been stated to have more than FNAC’s accuracy rate. FNAC stands as an active and reliable method in the pre-operative diagnosis of benign as the first line diagnostic modality but in malignant lesions to avoid any false negative result especially in older age group Tru-cut biopsy stands as more accurate diagnostic test.

FNAC has its advantage of being cost effective, fast, less time consuming and early reportability. FNAC can be done as O.P.D. procedure. FNAC has its advantage in aspiration of axillary lymph nodes in the case of metastasis where it is difficult to perform the core needle biopsy. Thus FNAC is preferred in the diagnosis of clinically benign appearing lesions. In case of malignant and potential malignant lesions fast and cost affectivity advantage of FNAC is irrelevant.

Tru-cut biopsy has advantage of higher accuracy giving appropriate information on tumour architecture and lympho-vascular invasion and in addition to that, on tru-cut biopsy block immunohistochemistry status also can be performed like ER, PR, Her-2 neu status which will help in planning of pre-operative neo-adjuvant chemotherapy. Disadvantages of tru-cut biopsy is complex procedure, specific instrument, costly than FNAC and taking more time to prepare report (approx. 6-7 days compared with 1-2 days for FNAC).

Limitations of the study

1. Sample Size: This study's relatively small sample size—only 75 patients per group—is one of its main drawbacks. Because of this, it's possible that the findings cannot be applied to a wider, more varied population, which would restrict their generalizability.
2. Absence Blinding: The study's design lacked blinding processes, which could have introduced selection bias and impacted the results' impartiality. To reduce bias and improve the validity of the findings, randomized controlled trials, meta-analysis should be taken into consideration in future research.

Recommendations

Randomization and Blinding: To reduce potential biases and enhance the validity of future research, it is recommended to utilize randomized controlled trials (RCTs) with blinding whenever possible. Blinding helps mitigate the influence of both the surgeon's and the patient's expectations on the outcomes, while randomization ensures an equitable distribution of patients across different diagnostic methods. Implementing these methodological improvements will provide stronger evidence supporting the accuracy of Tru-cut biopsy. Multicentric Studies with a Larger Participant Base: Future research should aim to include a broader and more diverse patient population from multiple centres to enhance the generalizability of the results. Conducting multicentric studies will allow for a more comprehensive evaluation of the diagnostic effectiveness of FNAC and Tru-cut biopsy, specifically assessing whether Tru-cut biopsy demonstrates greater accuracy compared to FNAC.

1. Kamal MZ, Banu NR, Alam MM, Das UK, Karmoker RK. Evaluation of Breast Lump - Comparison between True-cut Needle Biopsy and FNAC in MMCH: A Study of 100 Cases. Mymensingh Med J. 2020 Jan;29(1):48-54. PMID: 31915335.
2. Syeda Momena Hossain, Ali; Comparative Study of Tru-Cut Biopsy and FNAC in A Clinically Palpable Breast Lump; Ibrahim Card Med J 2021; 11 (1): 21-27
3. Pravalika F, Reddy MR, Prakash AB. Comparison between FNAC and TRU cut biopsy in patients with breast lump. International Journal of Surgery Science. 2024;8(1):07-13.
4. Rahman MZ, Sikder AM, Nabi SR. Diagnosis of breast lump by fine needle aspiration cytology and mammography. Mymensingh Med J. 2011 Oct;20(4):658-64. PMID: 22081186.
5. Kinjal JS, Faruq IM, Gupta M. Diagnostic Usefulness of Tru Cut Biopsy at a Tertiary Care Centre. J Med Sci Health 2023; 9(1):23-28
6. Tripathi K, Yadav R, Maurya SK. A Comparative Study Between Fine-Needle Aspiration Cytology and Core Needle Biopsy in Diagnosing Clinically Palpable Breast Lumps. Cureus. 2022 Aug 5;14(8):e27709. doi: 10.7759/cureus.27709. PMID: 36081980; PMCID: PMC9441185
7. Sharma M, Madan M, Manjari M, Singh T, Kaur K, Surbhi, Core needle biopsy verses fine needle aspiration cytology in palpable breast lesions- a comparative study. Indian J Pathol Oncol 2017;4(1):31-34
8. Siddique, Rizia; Sinha, Anuradha1; Adhikary, Moumita2; Phukan, Jyoti Prakash3,. Comparative Study of Fine-Needle Aspiration Cytology and Needle Core Biopsy in the Diagnosis of Breast Lumps with Histopathological Correlation. Journal of the Scientific Society 49(1):p 70-75, Jan–Apr 2022. | DOI: 10.4103/jss.jss_81_21
9. Hossain, S. M., Islam, M. B. ., Ali, M. S. ., Islam, I. ., & Naz, N. . (2022). Comparative Study of Tru-Cut Biopsy and FNAC in A Clinically Palpable Breast Lump. Ibrahim Cardiac Medical Journal, 11(1), 21–27.
10. Sharang S Kulkarni, Sheetal Murchite, Aniket Patil. A Comparative Study Between Fine Needle Aspiration Cytology and Core Needle Biopsy in the Diagnosis of Palpable Breast Lumps. Journal of Surgery and Research 5 (2022): 221-228.