SYNOPSIS

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

“ROLE OF FINE NEEDLE ASPIRATION CYTOLOGY IN

SUPERFICIAL LYMPHADENOPATHY”

Name of the candidate : Dr. De Souza Johanna Alba

Guide : Dr. Umaru N.

Course and Subject : M.D. (Pathology).

Department of Pathology,

A. J. Institute of Medical Sciences,

Kuntikana, Mangalore.

2013

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE.

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / Name of the candidate and address (in block letters) / DR. DE SOUZA JOHANNA ALBA
POST GRADUATE RESIDENT,(MD)
DEPARTMENT OF PATHOLOGY,
AJ INSTITUTE OF MEDICAL SCIENCES,
MANGALORE.
2 / Name of the Institution / A. J. INSTITUTE OF MEDICAL SCIENCES, MANGALORE.
3 / Course of study and Subject / MD. PATHOLOGY.
4 / Date of admission to course / 11/06/2013
5 / Title of the Topic:
ROLE OF FINE NEEDLE ASPIRATION CYTOLOGY IN SUPERFICIAL LYMPHADENOPATHY
6 / BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study
Lymphadenopathy is an age old affliction of mankind. It is one of the very common presentations in clinical practice. [1] Cervical lymph nodes are most commonly involved in all types of lymphadenopathy. Lymph node aspiration is of great value for the diagnosis of lymphadenitis, lymphomas and metastatic carcinoma. [2]
The primary purpose of FNA biopsy of abnormal peripheral lymph nodes is to decide whether surgical excision for histological examination is indicated. [3]
The aim of the present study is to evaluate the role of fine needle aspiration cytology in patients with superficial lymphadenopathy and to correlate with histopathology wherever possible.
6.2 Review of literature
FNAC is a simple, quick and inexpensive method that is used to sample superficial masses and is now considered a valuable diagnostic aid. [4,5]
Fine needle aspiration cytology (FNAC) is nowadays recognized as a rapid diagnostic technique because of its simplicity, cost effectiveness, early availability of results, accuracy and minimal invasion.[2]
Lymph nodes react to various stimuli and undergo changes leading on to a vast array of neoplastic or non- neoplastic proliferations.[4]
Lymphadenopathy is a commonly encountered clinical problem which has a multitude of causes. The commonest cause of peripheral lymphadenopathy is a non specific reactive hyperplasia in which the underlying etiology is infrequently found probably an asymptomatic inflammatory process.[6]
The likelihood of malignant disease as a cause of peripheral lymphadenopathy increases over the age of 40 years, nodes over 2cm in size, firm or matted nodes and non-tender or non painful nodes. In general practice less than 1% of patients with peripheral lymphadenopathy have a malignant process.[6]
Granuloma with caseous necrosis is the hallmark of tuberculous lymphadenitis .[6]
In developing countries like India, tuberculous lymphadenitis is one of the most common causes of lymphadenopathy. [7]
Hodgkin’s lymphoma is characterized by the classic Reed- Sternberg cells in a background of sarcoid like granulomata, reactive lymphoid cells and occasional eosinophils. [8] Non- necrotising sarcoidal type granulomata may also be seen with foreign body reactions, brucellosis, Crohn’s disease, leishmaniasis and leprosy. [6]
6.3 Objectives of the study
1. To study the cytological patterns in various superficial lymph node lesions
2. To correlate with histopathology wherever possible.
3. To study the spectrum of lesions with respect to age, gender and site of occurrence.
Materials and methods:
7.1 Source of data.
The present study will be undertaken at the Central Diagnostic Laboratory at A.J Institute of Medical Sciences, Mangalore. Patients of all age groups that are referred to the Central Diagnostic Laboratory for FNA of superficial lymph nodes will be enrolled for the study.
A minimum of 100 patients will be included.
7.2 Method of collection of data ( including sampling procedure, if any)
Patients of all age groups that are referred to the Central Diagnostic Laboratory at A.J.I.M.S for FNA of superficial lymph nodes during the study period will be enrolled for the study. The patient’s clinical details will be obtained. Examination findings and relevant investigation results will be noted. FNA will be performed after taking consent and explaining the procedure to the patient. The standard procedure for FNA will be adopted. All the slides of the cases will be reviewed and impression recorded.
Material: 5ml disposable syringe, 23-24 gauge needles, glass slides, cotton swab, spirit, Couplin’s jars, Hematoxylin & Eosin stain, Giemsa stain.
Sampling procedure: FNAC is performed as an outpatient procedure. Aseptic and universal precautions will be observed. No anaesthesia will be used. Skin over lymph node to be aspirated is cleaned with spirit. A 23-24 gauge needle attached to a syringe will be introduced into the lymph node. The needle is moved back and forth within the target tissue. The needle is withdrawn from the target tissue. One or two passes may be required. Aspirated material is spread on the slide. Air dried smears are stained with Giemsa stain and wet-fixed smears are stained with Papanicolaou. Few slides are stained with AFB for tuberculosis. The slides are examined under the microscope.
Duration of the study: Two year prospective study from July 2013 to June
2015.
Inclusion criteria:
1. Patients of all age groups that are referred to the Central Diagnostic Laboratory at A.J Institute of Medical Sciences for FNA of superficial lymph nodes during the study period.
2. FNAC that was provisionally thought to be non-lymphoid in origin, that later turned out to be that from a lymph node.
Exclusion criteria:
1. FNA of deep lymph nodes.
2. USG/ CT scan guided FNA of lymph node.
3. FNAC that was provisionally thought to be of lymph node origin that later turned out to be non-lymphoid origin.
4. Inadequate aspirate.
Plan for data analysis:
The data will be collected and statistical analysis will be done for sensitivity and specificity of FNAC diagnosis.
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, Aspiration of lesion with a fine gauge needle which is done as an outpatient procedure.
7.4 Has ethical clearance been obtained from your institution:
Yes
8 / LIST OF REFERENCES:
1. Patra DK, Nath S , Biswas K, Sarkar R, De J. Diagnostic evaluation of childhood cervical lymphadenopathy by fine needle aspiration cytology. J Indian Med Assoc 2007; 105 (12) : 694 – 6 , 698 – 9.
2. A.K. Kochhar , G. Duggal , K. Singh , S.K. Kochhar: Spectrum Of Cytological Findings In Patients With Lymphadenopathy In Rural Population Of Southern Haryana, India - Experience In A Tertiary Care Hospital. The Internet Journal of Pathology. 2012; 13(2).
3. S Giri, K Singh. Role of fine needle aspiration cytology in evaluation of patients with superficial lymphadenopathy. Int J Biol Med Res. 2012; 3(4): 2475-2479
4. D Agarwal, P Bansal, B Rani, S Sharma, S Chawla, V Bharat, S Sharma. Evaluation of etiology of lymphadenopathy in different age groups using Fine Needle Aspiration Cytology: A retrospective study. The Internet Journal of Pathology. 2009; 10(2).
5. T Ahmad, M Naeem, S Ahmad, A Samad. Fine Needle Aspiration Cytology (Fnac) And Neck Swellings In The Surgical Outpatient, J Ayub Med Coll Abbottabad 2008; 20(3): 30-32
6. Milauskas J. Lymph Nodes. In: Orell SR, Sterrett GF, editors. Fine Needle Aspiration Cytology. 5th ed. Churchill Livingstone, 2012; p. 77-117
7. Nidhi P, Sapna T, Shalini M, Kumud G. FNAC in tuberculous lymphadenitis: experience from a tertiary level referral centre. Indian J Tuberc. 2011; 58(3):102-7.
8. VKoo, TF Lioe, RAJ Spence. Fine needle aspiration cytology (FNAC) in the diagnosis of granulomatous lymphadenitis. Ulster Med J. 2006; 75(1): 59-64.
9 / Signature of candidate
10 / Remarks of the guide / It is a good study in which diagnosis can be done easily.
11 / 11.1 Name & designation of guide
(in block letters)
11.2 Signature / Dr. UMARU.N (MBBS, MD).
PROFESSOR AND HOD,
A. J. INSTITUTE OF MEDICAL SCIENCES,
MANGALORE.
11.3 Head of Department
11.4 Signature / Dr. UMARU.N MBBS.MD
PROFESSOR AND HOD,
A. J. INSTITUTE OF MEDICAL SCIENCES,
MANGALORE
12 / 12.1 Remarks of the
Chairman and Principal
12.2 Signature
PROFORMA
PATIENT DETAILS:
Serial Number: Hospital Number: Cytology Number:
Name:
Address:
Age: Sex:
CLINICAL DETAILS:
History:
Examination findings:
Investigations done:
Radiological diagnosis if any:
Provisional clinical diagnosis:
SITE OF FINE NEEDLE ASPIRATION:
MICROSCOPY:
IMPRESSION / CYTOLOGICAL DIAGNOSIS:
HISTOPATHOLOGICAL CORRELATION ( if available) :
FNAC/ Cytology Lab Consent form
NAME OF THE PATIENT :
HOSPITAL/ IP NUMBER:
I, the undersigned acknowledge that Dr.______has explained to me that I/ the Patient have / has to undergo Fine Needle Aspiration ( FNA) procedure, using syringe/ needle, for the diagnosis of my disease/ medical illness/condition.
I have been explained the need for this procedure, and its possible benefits, risks and complications such as syncope, pain, bleeding, hematoma, local hypersensitivity reaction and infection. I have understood the same and given my free and informed consent for the same to be performed and administration of any drug, as may be deemed fit by attending doctors.
I am also informed that in case of any complication arising during/ immediately after the FNA procedure, alternative treatment measures may be found necessary, for which I give my consent too. I further authorize the attending doctors for administration of appropriate drugs, IV fluids, blood/ blood components and hospital admission, as may be deemed fit, necessary or proper if required.
I certify and acknowledge that I have read and understood the contents of this form/ it has been read and explained to me in the language understood by me. Thus I understand the risks and have been made aware of the attending risks of the procedure I/ the Patient have to undergo.
NAME, AGE AND SIGNATURE OF PERSON GIVING THE ABOVE STATED CONSENT
RELATIONSHIP WITH THE PATIENT (If Applicable)
PATIENTS’S ADDRESS:
PHONE NUMBER:
E-MAIL ID:
DATE AND TIME:
NAME & SIGNATURE OF DOCTOR PERFORMING FNAC PROCEDURE:
NAME AND SIGNATURE OF THE DOCTOR TAKING THE CONSENT:
WITNESS ( NAME & SIGNATURE)
DOCTOR’S ADDITIONAL REMARKS ( If Any )

A. J. INSTITUTE OF MEDICAL SCIENCES,

KUNTIKANA, MANGALORE

Informed consent form for the patients of “A.J Institute of Medical Sciences Kuttikana, Mangalore”, who will be participating in the research project (MD PATHOLOGY dissertation) titled “ROLE OF FINE NEEDLE ASPIRATION CYTOLOGY IN SUPERFICIAL LYMPHADENOPATHY”.

Name of Principal Investigator / Dr. Umaru. N
HEAD OF DEPARTMENT.
Name of Organization / DEPARTMENT OF PATHOLOGY
A.J Medical Sciences, Kuttikana, Mangalore

This Informed Consent Form has two parts:

·  Information Sheet (to share information about the research with you)

·  Certificate of Consent (for signatures if you agree to take part)

You will be given a copy of the full Informed Consent Form

PART I: Information Sheet

Introduction

I, Dr. Johanna, Junior Resident in the Department of Pathology, A.J Institute of Medical Sciences, Kuttikana, Mangalore, is working on my MD dissertation titled “ROLE OF FINE NEEDLE ASPIRATION CYTOLOGY IN SUPERFICIAL LYMPHADENOPATHY”. My study subjects will include all age groups of patients who are referred to the Central Diagnostic Laboratory at AJIMS for FNAC of superficial lymph nodes.

I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research. Your decision to participate or not to participate will not have any effect on your treatment in our hospital. There may be some words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have questions later, you can ask them and get yourself clarified.

Purpose of the research

Lymph node enlargement is a common clinical problem which has many causes. Lymph node aspiration is of great value for the diagnosis of lymphadenitis (infection or inflammation) and malignancies. FNAC is a simple, painless, accurate, inexpensive diagnostic aid. It causes minimal invasion. It helps to decide whether surgical biopsy is indicated. A 23-24 gauge needle is used for Fine needle aspiration. The present study is conducted to evaluate the role of fine needle aspiration cytology in superficial lymphadenopathy.

Type of Research Intervention: It is a hospital based study. It is a two year study from July 2013 to June 2015. Patients of all age-groups (who satisfy inclusion and exclusion criteria) referred to the Central Diagnostic Laboratory at AJIMS for FNA of superficial lymph nodes during the study period will be enrolled for the study after providing informed consent to participation. FNA will be performed using a 23-24 gauge needle.

Participant selection

Patients of all age-groups presenting with superficial lymphadenopathy, who are referred to the Central Diagnostic Laboratory at AJIMS for FNA of superficial lymph nodes during the study period from July 2013 to June 2015 will be enrolled for the study

Voluntary Participation

Your participation in this research is entirely voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, it will not affect your treatment in our hospital. You have every right to withdraw at any stage in the research process.

Procedures and Protocol

Patients of all age-groups presenting with lymphadenopathy who are referred to the Central Diagnostic Laboratory at AJIMS for FNA of superficial lymph nodes during the study period from July 2013 to June 2015 will be enrolled for the study. The procedure will be explained. A minimum of 100 patients will be included.

Clinical details will be asked. Examination findings and relevant investigation results will be noted. The standard procedure for FNA will be adopted.

FNAC is performed as an outpatient procedure. Aseptic and universal precautions will be observed. No anaesthesia will be used. Skin over lymph node to be aspirated is cleaned with spirit. A 23-24 gauge needle attached to a syringe will be introduced into the lymph node. The needle is moved back and forth within the target tissue. The needle is withdrawn from the target tissue. One or two passes may be required. The slides stained and examined under the microscope and report will be given within 2 working days.

It is a relatively safe procedure. The risks and complications include syncope, pain, bleeding, hematoma, local hypersensitivity reaction and infection. In case of any complication arising during/ immediately after the FNA procedure, alternative treatment measures may be performed such as administration of appropriate drugs, IV fluids, blood/ blood components and hospital admission, as may be deemed fit, necessary or proper if required. While the possibility of this happening is very low, you should still be aware of the possibility. We will try to decrease the chances of this event occurring, but if something unexpected happens, we will provide you with the necessary medical care at AJIMS free of cost.