Download RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA
BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1
Name of the Candidate and Address
(in Block Letters)
Dr. GAURAV PARASHAR
PARASHAR NURSING HOME
RISHI NAGAR
HISAR-125001
HARYANA
2
Name of the Institution
J.J.M. MEDICAL COLLEGE
DAVANGERE – 577 004, KARNATAKA
3
Course of Study and Subject
POSTGRADUATE DEGREE
M.S. GENERAL SURGERY
4
Date of Admission to Course
5
Title of the Topic
27th MAY 2011
“SENTINEL LYMPH NODE BIOPSY
IN EARLY BREAST CANCER USING
METHYLENE BLUE”
6
BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
For nearly a century axillary lymph node dissection (ALND) has been
considered an essential component of breast cancer management. The benefits
of ALND include its impact on disease control (i.e. axillary recurrence and
survival), its prognostic value, and its role in treatment selection. However, the
anatomic disruption caused by ALND may result in lymphedema, nerve injury,
and shoulder dysfunction, which compromise functionality and quality of life.
ALND remains the standard approach for women who have clinically palpable
axillary nodes or positive nodes confirmed by methods such as ultrasound
guided fine needle aspiration.
The surgical approach to treating women who have clinically negative
axillary lymph nodes with breast cancer is rapidly evolving. For these patients,
sentinel lymph node biopsy (SLNB) is a method of staging the axilla.
SLNB offers its foremost advantage in nodal staging by allowing a more
focused examination of the lymph node at greatest risk for metastatic disease.
The benefits of SLNB for breast cancer patients with histologically negative
axillary nodes, in whom axillary lymph node dissection (ALND) is thereby
avoided, are now established.
Methylene blue is a good and cheaper agent for SLN mapping. Addition of
radio-colloid mapping to blue dye does not achieve a sufficiently higher
identification rate to justify the cost. Methylene blue is therefore the agent of
choice for SLN mapping in developing countries.1
The present study intends to do sentinel lymphadenectomy to detect axillary
lymph node metastases in patients with early breast cancer.
6.2 Review of Literature

In 1992, Morton and colleagues described lymphatic mapping utilizing an
intradermal isosulfan blue dye injection technique for malignant melanoma
and were the first to employ this concept to localize SLN in patients with
malignant melanoma.2

Giuliano applied intra parenchymal blue dye lymphatic mapping to the
nodal evaluation of breast cancer.2

Sentinel node biopsy (SNB) is an appropriate initial alternative to routine
staging ALND for patients with early-stage breast cancer with clinically
negative axillary nodes.3

Lymphatic mapping with SLNB is used widely to reduce the complications
associated with ALND in patients with low-risk breast carcinoma.4

Giuliano et al5 reported no axillary recurrence in patients who had a
histologically negative SNB and no further axillary node dissection after a
median follow up of 39 months. Furthermore, they reported a higher
complication rate in patients who had complete axillary node dissection
compared with those who had an SNB only.

Intra-operative lymphatic mapping and sentinel lymph node biopsy is a
highly accurate, minimally invasive, safe and cheap method for staging of
patients with breast cancer favoring more conservative treatment.6

SLNB is effective in early breast cancer patients of Indian population. SLNB
using combination of methylene blue dye and radio-active Tc99m sulphur
colloid can stage the axilla with high accuracy & low risk of false negativity
in early breast cancer patients.7

The technique of identifying the sentinel node(s) by using subareolar
methylene blue has sufficiently high technical success rate (97%) and
negative predictive value (96%) to allow its useful application in women
with invasive breast cancer and clinically negative axilla.8

The subareolar injection of technetium is as accurate as peritumoral injection
of blue dye. Central injection is easy and avoids the necessity for image
guided injection of non palpable breast lesions. Finally subareolar injection
of technetium avoids the problem of overlap of the radioactive zone of
diffusion of injection site with the radioactive sentinel lymph node,
particularly in medial and upper outer quadrant lesions.9

In multi-institutional practice, SLNB using dual-agent injection provides
optimal sensitivity for detection of nodal metastases. The acceptable SLN
identification and false-negative rates associated with the dual-agent
injection technique indicate that this procedure is a suitable alternative to
routine axillary dissection across a wide spectrum of surgical practice and
hospital environments.10
6.3 Objectives of the Study:

To assess the efficacy of sentinel lymph node biopsy in detecting axillary
metastasis in cases of node negative early breast cancer.
7.
MATERIALS AND METHODS
7.1 Source of Data:
The patients admitted to Chigateri general hospital and Bapuji hospital
attached to J.J.M. Medical College, Davangere with primary diagnosis of early
breast cancer will be taken for this prospective study from June 2011 to May
2013 (2 years).
7.2 Method of collection of Data (including sampling procedures if any):

Female patients who are admitted with primary diagnosis of early breast
cancer, clinical stage T1/T2 N0M0, based on detailed history, clinical
examination, FNAC/Trucut biopsy, USG breast and axilla, USG abdomen,
mammography and chest x-ray will be selected for this study.

These patients will be subjected to the required preoperative investigations.
After ensuring fitness for surgery, these patients will be taken for modified
radical mastectomy.

Methylene blue dye will be injected in subareolar region 20 minutes prior to
surgery. Intraoperatively, sentinel lymph node will be searched after raising
upper flap. Dissection of axillary tissue to identify stained lymph node will
be done. After excising the stained lymph nodes, complete axillary clearance
and removal of breast tissue will be done.

Lymph nodes will be divided into two groups: the dye stained lymph node
as Sentinel Node and the rest of the lymph nodes removed by axillary
clearance. These along with the breast specimen will be sent for
histopathology, marked and labelled accordingly. Pathological data will
include histopathological type, size of the tumor, ER/PR status, HeR2Neu
status, lymph node status in sentinel and non sentinel lymph nodes.
A minimum of 30 cases with the following inclusion and exclusion criteria
will be selected for the study.
Inclusion criteria :

Patients with pathologically (FNAC/Trucut biopsy) proved early breast
cancer without clinically palpable nodes, clinical stage T1/T2 N0 M0, will
be selected for this study.
Exclusion criteria :

Pregnant/lactating patients.

Patients with clinically palpable nodes.

Patients with primary breast lesions clinically larger than 5cm.

Patients with multicentric and multifocal tumor.

Patients with systemic metastasis.

Patients with previous breast surgery that may interfere with the lymphatic
drainage.

Patients with previous radiotherapy and/or chemotherapy.

Patients who are allergic to methylene blue dye.
A pretested proforma will be used to collect relevant information (patient
data, clinical findings, lab investigations, etc.) from all the selected patients.
Statistical analysis:
Diagnostic Validity Tests will be performed to assess the efficacy of sentinel
lymph node biopsy in detecting axillary metastasis in early breast cancer using
methylene blue.
7.3 Does the Study require any investigations or interventions to be conducted
on patients or other humans or animals? If so please describe briefly.
Yes

Hb% , TC, DC, ESR, BT, CT

RBS , Blood urea, Serum creatinine

Blood grouping, cross matching

HIV-1&2

HBsAg

Liver Function Tests

ECG

FNAC/Trucut biopsy

USG BREAST AND AXILLA

Mammography

Chest X-ray

USG abdomen
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes
8.
LIST OF REFERENCES:
1)
Jeffrey ME, Valentine CSP, Kanchev EO, Blake G. Sentinel lymph node
biopsy for breast cancer using methylene blue dye manifests a short learning
curve among experienced surgeons: a prospective tabular cumulative sum
(CUSUM) analysis.BMC Surgery 2009; 9(2). doi:10.1186/1471-2482-9-2.
Available from: http://www.biomedcentral.com/1471-2482/9/2.
2)
Jakub JW, Pendas S, Reintgen DS. Current Status of Sentinel Lymph Node
Mapping and Biopsy: Facts and Controversies. The Oncologist 2003;8:59-68
3)
Lyman GH, Giuliano AE, Somerfield ME, Benson III AB, Bodurka DC,
Burstein HJ, et al. American Society of Clinical Oncology Guideline
Recommendations for Sentinel Lymph Node Biopsy in Early-Stage Breast
Cancer. J Clin Oncol Oct. 2005; 23(30):7703-7720.
4)
Theodore K, Giuliano AE, Lyman GH. Lymphatic Mapping and Sentinel
Lymph Node Biopsy in Early-Stage Breast Carcinoma-A Metaanalysis.
CANCER Jan 1, 2006; 106(1):4-16.
5)
Giuliano AE, Haigh PI, Brennan MB, Hansen NM, Kelley MC, Ye W, et al.
Prospective observational study of sentinel lymphadenectomy without further
axillary dissection in patients with sentinel node-negative breast cancer. J Clin
Oncol, July 2000; 18 (13): 2553-2559.
6)
Shoma AM, Moatamed A, O Shouman, El-Sedeek M. Lymphatic Mapping
and Sentinel Lymphadenectomy in Breast Cancer. Egyptian Journal of
Surgery Jan.2001; 20(1):418-426.
7)
Somashekhar SP, Shabber SZ, Venkatesh KU, Venkatachala K, Thirumalai
MM. Sentinel lymph node biopsy in early breast cancer using methylene blue
dye and radioactive sulphur colloid — a single institution Indian
experience.IJS 2008; 70(3):111-119.
8)
Mokbel K, Mostafa A. The Role of Subareolar Blue Dye in Identifying the
Sentinel Node in Patients with Invasive Breast Cancer. Current Medical
Research and Opinion, 2001; 17(2): 93-95.
9)
Klimberg VS, Rubio IT, Henry R, Cowan C,Colvert M, Korourian S.
Subareoler versus peritumoral injection for location of the sentinel lymph
node. Ann Surg 1999; 229 (6):860-865.
10)
McMasters KM, Tuttle TM, Carlson DJ, Brown CM, Noyes RD, Glaser RL,
Vennekotter DJ, Turk PS, Tate PS, Sardi A, Cerrito PB, Edwards MJ. Sentinel
lymph node biopsy for breast cancer: a suitable alternative to routine axillary
dissection in multi-institutional practice when optimal technique is used. J
Clin Oncol 2000; 18(13):2560-66.
9.
Signature of the Candidate
10. Remarks of the Guide
11. Name & Designation(in block letters)
11.1 Guide
11.2
Signature
11.3
Co-Guide (If any)
11.4
Signature
11.5
Head of the Department
Sentinel lymph node biopsy (SLNB) is
an appropriate initial alternative to
routine staging axillary lymph node
dissection (ALND) for patients with
early stage breast cancer with clinically
negative axillary nodes. Complete ALND
remains standard treatment for patients
with axillary metastasis identified on
SLNB. Some recommend 20 SLNB to be
performed
for
development
of
competence. Many studies suggest that
subareolar injection of methylene blue is
as accurate as peritumoral injection of
dye. Methylene blue is cheaper and this
technique is simpler with many
advantages. This study attempts to test
the efficacy of SLNB in predicting
axillary metastasis using subareolar
methylene blue dye injection in early
breast cancer patients with clinically
negative axillary nodes.
Dr. DINESH M. GUNASAGAR, M.S
PROFESSOR IN GENERAL
SURGERY DEPT OF GENERAL
SURGERY,
J.J.M MEDICAL COLLEGE,
DAVANGERE-577004
-None -
Dr. R.L. CHANDRASHEKAR M.S
DEPT OF GENERAL SURGERY,
J.J.M.MEDICAL COLLEGE,
DAVANGERE-577004
11.6
12
Signature
12.1 Remarks of the Chairman & the
Principal
12.2 Signature