This document outlines a proposed study to validate the use of sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer. The study aims to evaluate the accuracy of SLNB compared to axillary lymph node dissection and assess its ability to reduce morbidity. Forty early stage breast cancer patients will undergo SLNB using methylene blue dye and ultrasound guidance. The sentinel lymph nodes will be examined intraoperatively via frozen section and subsequently through histopathology. Results will be analyzed to determine sensitivity, accuracy, and predictive values of SLNB compared to final histopathology reports. The study aims to demonstrate whether SLNB can accurately identify lymph node involvement and avoid unnecessary axillary lymph node dissection in early stage breast cancer patients.

1. PT. B.D. SHARMA UNIVERSITY OF HEALTH
SCIENCES, ROHTAK
• Proposed subject of THESIS : To validate the Sentinel Lymph Node Biopsy in patients of
early stage breast cancer
Dr. Manoj,
Post Graduate Student
Department of General Surgery
Pt. B.D. Sharma PGIMS,
Rohtak
Dr. Nityasha Dalal
Senior Professor
Department of General Surgery
Pt. B.D. Sharma PGIMS, Rohtak
(SUPERVISOR)

2. ETHICAL JUSTIFICATION
All the procedures mentioned in material and method section of present study plan are standard procedure
worldwide. No unethical tests or procedures will be employed during this study. Hence this study is ethically
justified. However, the proposed study “To validate the Sentinel Lymph Node Biopsy in patients of early
stage breast cancer” will be undertaken after getting informed consent from the enrolled patients.
Dr. Manoj,
Post Graduate Student
Department of General Surgery
Pt. B.D. Sharma PGIMS,
Rohtak
Dr. Nityasha Dalal
Senior Professor
Department of General Surgery
Pt. B.D. Sharma PGIMS,
Rohtak
(SUPERVISOR)
Dr. Hans Raj Ranga
Senior Professor and Unit Head
Chairman PG Board of Studies in Surgery
Department of General Surgery
Pt. B.D. Sharma PGIMS, Rohtak
Dr. M G Vashist
Sr. Professor and Head
Department of General Surgery
Pt. B.D. Sharma PGIMS,
Rohtak

3. INTRODUCTION
• Breast cancer is the most common type of cancer
among women worldwide. Early stage breast cancer is
characterized by small tumors that have not yet spread
to other parts of the body.
• Sentinel Lymph Node Biopsy (SLNB) is a surgical
technique used to determine if cancer has spread to the
lymph nodes near the breast. The role of SLNB in
patients with early stage breast cancer is a topic of
ongoing debate.

4. • The purpose of this presentation is to explore the evidence supporting the use of SLNB in patients with early stage breast
cancer and to evaluate its impact on patient outcomes.
• Patients with breast carcinoma, axillary LN status is a significant prognostic factor and care determinant.
• Surgical management of the axilla in women with invasive breast cancer has changed considerably in the last two decades:
sentinel node biopsy (SNB) has replaced axillary lymph node dissection (ALND) as the primary surgical staging approach.
• Currently, patients identified by SLNB with node-positive disease frequently undergo a complete ALND and further surgical
and medical management as indicated by their pathology.
• In the 1990s the standard of surgical practice has moved from complete ALND to sampling level I and II lymph nodes. The
most recent development is performing axillary SLNB. Patients without clinical involvement of the axilla should undergo
SLNB routinely, and no additional lymph node surgery is needed when the sentinel node is disease-free.

5. RESEARCH QUESTION
Can sentinel lymph node biopsy reduce axillary node dissection morbidities in patients of early breast cancer ?

6. AIM AND OBJECTIVES
AIM:
• To validate the Sentinel Lymph Node Biopsy in patients of early stage breast cancer.
OBJECTIVES:
• To study the positive sentinel lymph node biopsy in case of early stage breast cancer.
• To study Negative Sentinal Lymph Node rate in patients where axillary lymph node dissection
is avoided.
• To correlate clinical findings and USG findings with SLN Biopsy and Histopathology report.

7. MATERIALAND METHODS
• Study Design: Randomized prospective study.
• Study period: 1 year (May 2023 to May 2024).
• Sample size and sampling technique: A total of 40 patients will
be recruited in this study by non-random purposive sampling.

8. Inclusion Criteria:
• Female’s patients with early-stage breast cancer of any age
and pathology (T1 and T2 N0 M0) will be included
Exclusion Criteria:
• Patient with clinically palpable and radiologically
detectable nodes.
• Locally advanced breast cancer (T3 and T4 with any N,
M0).
• Metastatic breast cancer (any T and N with M1).
• Male breast cancer.

9. METHOD:
• Forty female patients diagnosed with early- stage breast
cancer (T1 and T2 N0 M0) with indeterminate axillary nodes
will be admitted .
• Sensitivity, accuracy, and positive and negative predictive
values of preoperative FNAC vs upfront intraoperative
SLNB and frozen portion of indeterminate axillary LNs will
be evaluated using Methylene Blue dye and contrasted, and
both findings will be correlated with the final results of the
histopathological paraffin portion.

10. • Statistical analysis will be done using SPSS software19.0. Data obtained will be tabulated in the
Excel sheet and will be analyzed.
• All values are expressed as mean + standard deviation and non-parametric data will be
expressed as median and min-max values. Chi-square test for proportions in qualitative data.
• Student’s unpaired t–test for Quantitative data. Tests of diagnostic accuracy such as Sensitivity,
specificity, Positive predictive value, and negative predictive value with 95% confidence level
will be calculated.
• P<0.05 is considered statistically significant.
STATISTICALANALYSIS

11. PROFORMA
NAME:
IN PATIENT NUMBER:
AGE /SEX:
ADDRESS
DATE OF ADMISSION:
DATE OF OPERATION:
DATE OF DISCHARGE:
RELIGION:
OCCUPATION:
SOCIOECONOMIC STATUS:
(According to modified Kuppuswamy scale) URBAN /
RURAL
LITERATE /IILLITERATE
COMPLAINTS AND DURATION
CLINICAL STAGE :
MAMOGRAPHY :
Core biopsy of breast primary :

12. FNAC of axilla, if positive
SLNB finding :
Final Histopathology report and immunohistochemistry :
(Signature of Candidate)