RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

TOPIC

DIAGNOSTIC ACCURACY OF B-MODE, COLOR DOPPLER, ELASTOGRAPHY WITH FNAC CORRELATION

IN EVALUATION OF CERVICAL LYMPHADENOPATHY

BY

DR SHRIKANT MOHAN PULKANTWAR

POST GRADUATE STUDENT

DEPARTMENT OF RADIO DIAGNOSIS

KVG MEDICAL COLLEGE AND HOSPITAL, SULLIA,

DAKSHINA KANNADA, KARNATAKA - 574327

UNDER GUIDANCE OF:

DR GOWTHAM GOWDA AG

PROFESSOR AND HEAD OF DEPARTMENT,

 DEPARTMENT OF RADIODIAGNOSIS,

KVG MEDICAL COLLEGE AND HOSPITAL, SULLIA

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

NAME OF THE CANDIDATE DR SHRIKANT MOHAN PULKANTWAR

1.
AND ADDRESS
POST GRADUATE STUDENT,

DEPARTMENT OF RADIODIAGNOSIS,

KVG MEDICAL COLLEGE AND HOSPITAL,

SULLIA, DAKSHINA KANNADA, 574327

2. NAME OF THE KVG MEDICAL COLLEGE AND HOSPITAL

INSTITUTION
SULLIA, DAKSHINA KANNADA - 574327.

3. COURSE OF STUDY AND M.D. RADIODIAGNOSIS

SUBJECT

4. DATE OF ADMISSION TO 27/11/2022

 COURSE

5 TITLE OF THE TOPIC DIAGNOSTIC ACCURACY OF B-MODE, COLOR DOPPLER,

ELASTOGRAPHY WITH FNAC CORRELATION IN EVALUATION

OF CERVICAL LYMPHADENOPATHY

6. Brief Introduction of the intended work:

6.1 Need for study:

1.INTRODUCTION:
One of the most common cause for mass in head and neck region is cervical lymphadenopathy.
There are various causes of cervical lymphadenopathy common among them being reactive,
tuberculosis, metastasis and lymphoma.1

Although clinical examination remains important in day to day practice however it is frequently
inadequate for distinguishing between benign and malignant cause which is crucial in
prognostication and further treatment planning.2

In evaluation of cervical lymphadenopathy, imaging plays an important role especially in

distinguishing between benign and malignant etiology. Almost all diagnostic imaging modalities
(CT, MRI, USG) have been found to have superior diagnostic accuracy as compared to physical
examination. Ultrasonography has long been utilized to assess cervical lymph nodes. The
addition of color Doppler has further increased diagnostic accuracy. 3

Wider accessibility, availability of high frequency probes with greater resolution, no radiation
issues and real time examination in multiple planes with feasibility for USG guided aspiration
cytology/histopathology whenever needed are few of advantages of USG. 3
Real time elastography being a novel, noninvasive imaging modality that assesses tissue
elasticity by comparing local tissue displacement from US signals before and after the
application of a compressive force. Under the compression of a transducer stiff tissues show
less deformation (strain) than soft tissues. Since malignant tissues are stiffer than their benign
counterparts at many sites, several reports have documented the utility of US elastography in
differentiating malignant from benign lesions in the breast, prostate, liver, thyroid, and cervix. 4

In recent years, multiple studies have evaluated ultrasound elastography (USE) for cancer
detection in the head and neck. While FNAC is the best method to differentiate benign from
malignant lesions but is minimally invasive and time consuming and therefore ultrasonography,
Doppler and elastography can be used in this to discriminate benign and malignant masses. 5

Due to insufficient data pertaining to the diagnostic accuracy of Ultrasonography, Doppler and
Elastography with FNAC correlation in evaluation of cervical lymph nodes, this study is taken
up.

6.2 Review of the literature: -

1. Singh AK et al (2015) came with conclusion that High resolution

ultrasonographic examination proved as a valuable primary investigation to

identify lymph nodes and differentiate nonneoplastic with neoplastic etiology.

Combination of ultrasonographic features with vascular pattern of the lymph

nodes have high sensitivity, specificity in differentiating between neoplastic and

nonneoplastic etiology. 1

2. Pattanayak MS et al (2018) concluded that individual parameters of B Mode

when used alone were not found to be very effective in differentiating benign

and malignant lymph nodes with sensitivity of 88% and specificity of 97.3%.

However features of B-Mode combined together as well as color Doppler

ultrasound, help in the detection of reactive lymph nodes and can be used as a

diagnostic tool with good accuracy. For color Doppler sensitivity was 92% and

specificity was 97.3%. 2

3. Kanagaraju V et al (2020) concluded that elastography has a high diagnostic

accuracy in differentiating benign and malignant cervical LNs and can be

potentially useful in selecting the LN with high probability of malignancy, on

which fine-needle aspiration cytology/biopsy can be performed.4

4. Alam F et al (2008) concluded thst the combination of highly specific

elastography with highly sensitive conventional B-mode sonography has the

potential to further improve the diagnosis of metastatic cervical lymph nodes. 7

5. Ying M et al (2013) concluded that ultrasonography is a useful and reliable

imaging method in the assessment of malignant cervical nodes in patients with

head and neck cancer. It helps to identify abnormal nodes and evaluate

treatment response. Grey scale ultrasonography assesses the size, distribution

and internal architecture of lymph nodes. Doppler ultrasonography evaluates the

intranodal vascular pattern and resistance of lymph nodes. Contrast enhanced

provides information on lymph node parenchymal perfusion. Elastography

allows qualitative and quantitative assessment of lymph node stiffness. 8

6. Elzawawy et al (2017) concluded that high resolution ultrasonography has an

important role in differentiating benign and malignant lymphadenopathy based

on the shape (longitudinal/transverse ratio), hila, cortical thickness, cortical

echogenicity, intranodal necrosis, pattern of vascularity, and resistivity index of

the nodes.9

7. Rohan K et al (2020) concluded that malignant nodes had significantly higher

SAD, higher S/L ratio, loss of echogenic hilum, presence of ill-defined margins and

peripheral/mixed vascularity compared to benign nodes. The loss of echogenic

hilum was the most accurate and sensitive parameter, while the S/L ratio was

found to be the most specific B Mode ultrasound parameter in the detection of

malignant nodes. B Mode ultrasound and Color Doppler ultrasound identify

malignant nodes and also helps in guiding FNAC/biopsy.10

8. Ghajarzadeh M et al (2014) concluded that Sono-elastograohy has high

accuracy in differentiating benign and malignant cervical LNs. The summary

sensitivity of the scoring and SR measurements for the differentiation of benign

and malignant LNs were 0.76 (95% confidence interval [CI]: 0.71–0.8) and 0.83

(95% CI: 0.78–0.87). The summary specificities were 0.8 (95% CI: 0.75–0.84) and

0.84 (95% CI: 0.79–0.88), respectively.11

9. Herman J et al (2019) concluded that the sensitivity and specificity of standard

ultrasound parameters in discriminating benign from malignant cervical lymph

nodes were shown to be somewhat better than a qualified estimate based on

epidemiologic data. In the study, elastography (maximum stiffness) improved the

performance of standard ultrasound marginally only. The type of malignancy

and the number of lesions evaluated influence the results of elastography studies

of cervical lymph nodes.12

10. Gupta R et al (2017) concluded that elastography is a useful tool in addition to

B-mode and color doppler ultrasound for evaluation of cervical lymph nodes.

Elastography pattern and strain ratio are more accurate than B-mode and color

doppler for differentiating benign from malignant lymph nodes. It adds very little

time to total examination time and can be performed in same setting when

patient presents for routine ultrasound. Therefore, it may be routinely used for
gathering additional information in assessment of cervical lymph nodes.13

11. Chae SY et al (2019) study showed that SWE can be a useful tool to

discriminate metastatic cervical LN from lymphoma with improvement of

diagnostic accuracy when using with conventional US. Furthermore, SWE may

improve accuracy without too much time consuming for especially less-

experienced radiologists. SWE along with B mode and color Doppler will further

improve in coming to the diagnosis and differentiating between benign and

malignant etiology.14

12. Raja Lakshmi C et al (2014) came with conclusion that Lymph node evaluation

can be accomplished with various modalities like CT, MRI, PET, and

radionucleotide imaging; however these are expensive and not widely available.

The present study was one such attempt to prove the efficacy of ultrasound which

is nonionizing, noninvasive, cost effective, and easily available in differentiating

benign and metastatic cervical group of lymph nodes. From the current study we

conclude that cervical group of lymph nodes with ultrasonographic features such

as round shape, absence of hilar echo, sharp nodal borders, hypoehoic internal

echogenicity and presence of intranodal necrosis were highly suggestive of

metastatic cervical lymph nodes; however nodal borders and echogenic hilum

criteria revealed high sensitivity and specificity of 100%.15

13. Kallalli BN et al (2020) concluded that only clinical examination is not

sufficient in evaluation of cervical lymphadenopathy. Additional diagnostic

investigations should be done along with clinical examinations. In comparison

with CT having sensitivity 81% and specificity 84%, Ultrasound modality had

higher sensitivity 92% and specificity 93%.16

14. Naik RM et al (2012) concluded that color doppler ultrasound can show flow
 in all lymph nodes, regardless of whether they are affected by a benign or a

malignant process. The analysis of patterns of nodal vascularity can be used to

differentiate benign from malignant lymphadenopathy with high sensitivity.

Doppler indices are also useful in the diagnosis of malignant lymphadenopathy

with high specificity.17

15. Misra D et al (2016) concluded that CDUS examination is a valuable and a

highly specific diagnostic tool in differentiating cervical lymphadenopathy over

clinical and histopathological examination.18

6.3 Objectives of the study:

1. To find out diagnostic efficacy of B-mode, color Doppler and Elastography

in evaluation of cervical lymphadenopathy.

2. To find out and compare accuracy between B-mode, color Doppler and

Elastography in diagnosing the cause.

7. MATERIALS AND METHODS:

Source of data:All patients with cervical lymphadenopathy attending KVG

Medical College & hospital, Sullia.

All patients diagnosed with cervical lymphadenopathy in routine USG neck scan,

attending radiology department of KVG Medical College & hospital, Sullia.

Study area: DEPARTMENT OF RADIO DIAGNOSIS K V G MEDICAL COLLEGE AND

HOSPITAL, SULLIA
Study period: 18 months ( JUNE 2023 to NOVEMBER 2024)

Study design: Cross sectional study

SAMPLE SIZE:

Minimum sample size is calculated as follows using the formula n=4pq/l2, where

n= sample size

L is allowable error= +-5

P= Accuracy= 94%. Accuracy is 94% as per the study done by Vikrant Kanagaraju.4

q=(100-p) = 100-94=6

n=4pq/l2 = 4 X 94 X 6/ 5 X 5 = 90.24 ≈ 90

Hence a sample size of 90 thyroid nodules subjects, who meet inclusion and

exclusion criteria, falling within my sampling frame and attending radiology

department of KVG Medical College & hospital, Sullia, will be taken.

SAMPLING TECHNIQUE: Universal sampling, All consecutive participants who

fits the inclusion criteria will be selected for the study

SELECTION CRITERIA :

Inclusion criteria:

1. All Patients clinically presenting with cervical lymphadenopathy

2. Patients who are willing to participate in the study.

Exclusion criteria:

1. Patients under the age of 18 years.

2. Patients with bleeding tendency.
Operational definition:

Cervical lymphadenopathy refers to lymphadenopathy of the cervical lymph nodes (the glands in
the neck). The term lymphadenopathy strictly speaking refers to disease of the lymph nodes 6,
though it is often used to describe the enlargement of the lymph nodes.

Method of collection:

After the permission from instructional ethical committee, participants presenting with cervical
lymphadenopathy and satisfying the inclusion and exclusion criteria will participate in the study.

• B mode Ultrasonography, Doppler and Elastography will be done.

•A written informed consent will be taken prior to the insertion of needle for FNAC.

•Further FNAC will be taken under local anaesthesia and sample will be sent for cytological
examination.

DATA COLLECTING TOOLS:

IMAGING TECHNIQUE:

Ultrasonography , Doppler will be done on OPD basis using Phillips Affinity model 70G
machine.

Elastography will done using Phillips Affinity modelmodel 70 G machine.

Ultrasound, doppler and elastography will be performed consequently in the patients with
thyroid masses , with the patient lying down in supine position with an elevation given under the
neck to provide proper visualization.

Statistical analysis:

All data will be collected and kept confidential and entered into excel sheet and will be utilized
 for further analysis.

As this is a cross sectional study , sensitivity , specificity , positive predictive value , negative
predictive value , Cohen kappa and all analysis will be calculated using EPI INFO SOFTWARE
VERSION 7. and final conclusion will be drawn after comparing with FNAC.

Follow up: Not required.

Follow up period: Not applicable.

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. Ultrasound Elastography (Fibroscan).

7.4 Has ethical clearance been obtained from ethical committee of your institution

in case of 7.3?

Yes.

8 References:

1-Singh AK, Hegde P, Sakalecha AK, Suresh TN, and Sreeramulu PN. EVALUATION OF
CERVICAL LYMPH NODES BY ULTRASONOGRAPHY IN CORRELATION WITH
FNAC. Journal of Evolution of Medical and Dental Sciences 2015;04(09):1533-1551.

2-Pattanayak MS, Chatterjee CS, Ravikumar BR, Nijhawan BVS, Sharma BV and Debnath CJ.
Ultrasound evaluation of cervical lymphadenopathy: Can it reduce the need of
histopathology/cytopathology?. Med J Armed Forces India 2018;74(3):227-234.

3- Phelps PD. The pharynx and larynx: the neck. In: Sutton D. In:Text Book of Radiology and
Imaging. 7th ed. vol. 2. Churchill Livingstone; New Delhi: 2003:1489–1517.

4-Kanagaraju V, Rakshith AVB, Devan B and Rajakumar R. Utility of ultrasound elastography

to differentiate benign from malignant cervical lymph nodes. J Med Ultrasound 2020;28(2):92-
98.

5-Lacout A, Chevenet C, Thariat J, Figl A, Marcy PY. Qualitative ultrasound elastography

assessment of benign thyroid nodules: Patterns and intra-observer acquisition variability. India J
Radiol 2013;23(4):337-341.

6-Kerawala C, Newlands C, eds. Oral and maxillofacial surgery. Oxford: Oxford University
Press 2010:68, 377, 392–94.

7-Alam F, Naito K, Horiguchi J, Fukuda H, Tachikake T and Ito K. Accuracy of Sonographic

Elastography in the Differential Diagnosis of Enlarged Cervical Lymph Nodes: Comparison with
Conventional B-Mode Sonography. American Journal of Roentgenology 2008; 191(2):604-610.

8-Ying M, Bhatia K, Lee Y, Yuen H and Ahuja A.. Review of ultrasonography of malignant
neck nodes: greyscale, Doppler, contrast enhancement and elastography. Cancer Imaging
2013;13(4):658-669.

9-Mohamed S, Elzawawy, Sameh M, Azab, Reham M. Elshiekh. Role of color Doppler

ultrasonography in differentiating benign and malignant cervical lymphadenopathy. Menoufia
Medical Journal 2018;31(3):1030-1035.

10-Rohan K, Ramesh A, Sureshkumar S, Vijayakumar C, Abdulbasith KM and Krishnaraj B.

Evaluation of B-Mode and Color Doppler Ultrasound in the Diagnosis of Malignant Cervical
Lymphadenopathy. Cureus 2020;12(8):e9819.

11-Ghajarzadeh M, Mohammadifar M, Azarkhish K, Emami-Razavi SH. Sono-elastography for

Differentiating Benign and Malignant Cervical Lymph Nodes: A Systematic Review and Meta-
 Analysis. Int J Prev Med 2014;5(12):1521-1528.

12-Heřman J, Sedláčková Z, Fürst T, Vachutka J, Salzman R, Vomáčka J et al. The Role of

Ultrasound and Shear-Wave Elastography in Evaluation of Cervical Lymph Nodes. BioMed
Research International 2019: 1-6.

13-Gupta R, Mittal P, Kaur T, Kaur H, Aamir M and Malik R. Ultrasound Elastography for
Differentiating Benign from Malignant Cervical Lymphadenopathy: Comparison with B-Mode
and Color Doppler Findings. JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH
2017;11(12):TC05-TC08.

14-Chae SY, Jung HN, Ryoo I and Suh S. Differentiating cervical metastatic lymphadenopathy
and lymphoma by shear wave elastography. Sci Rep 2019;9:12396.

15-Raja Lakshmi C, Rao SM., Ravikiran A, Sathish S and Bhavana SM. Evaluation of
Reliability of Ultrasonographic Parameters in Differentiating Benign and Metastatic Cervical
Group of Lymph Nodes. ISRN Otolaryngol 2014;2014:238740.

16-Kallalli, NB, Rawson, Kamala, Kumari, Veena et al. Comparison between clinical
examination, ultrasonography, and computed tomography in assessment of cervical lymph node
metastasis in oral squamous cell carcinoma. J Indian Acad Oral Med Radiol 2016;28(4):364-369.

17-Naik RM, Pai A, Guruprasad Y and Singh R. Efficacy of Colour Doppler Ultrasound in
Diagnosis of Cervical Lymphadenopathy. J Maxillofac Oral Surg 2013;12(2):123-129 .

18-Misra D, Panjwani S, Rai S, Misra A, Prabhat M, Gupta P et al. Diagnostic efficacy of color
Doppler ultrasound in evaluation of cervical lymphadenopathy. Dental Research Journal
2016;13(3):217-224.

9. Signature of Candidate:
 (DR. SHRIKANT PULKANTWAR)

10 Remarks of the Guide:

11 NAME AND DESIGNATION

OF
DR GOWTHAM GOWDA AG
11.1 Guide:
PROFESSOR AND HEAD OF DEPT,

DEPARTMENT OF RADIODIAGNOSIS,

KVG MEDICAL COLLEGE, SULLIA

11.2 Signature:
 11.3 Head of the Department: DR GOWTHAM GOWDA AG

PROFESSOR AND HEAD OF DEPARTMENT,

DEPARTMENT OF RADIODIAGNOSIS,

KVG MEDICAL COLLEGE, SULLIA

11.4. Signature:

12 12.1. Remarks of the Principal:

12.2. Principal’s Signature:

 INSTITUTIONAL ETHICS COMMITTEE CLEARANCE

1. TITLE OF DISSERTATION “DIAGNOSTIC ACCURACY OF B-MODE, COLOR DOPPLER,

ELASTOGRAPHY WITH FNAC CORRELATION IN
EVALUATION OF CERVICAL LYMPHADENOPATHY.

2. NAME OF THE CANDIDATE DR. SHRIKANT MOHAN PULKANTWAR

3. NAME OF THE GUIDE DR GOWTHAM GOWDA AG

PROFESSOR AND HEAD OF DEPARTMENT,

DEPARTMENT OF RADIODIAGNOSIS,

KVG MEDICAL COLLEGE, SULLIA

4. NAME OF THE CO GUIDE NOT APPLICABLE

5. APPROVED/ NOT APPROVED APPROVED

ETHICS COMMITTEE

CHAIRPERSON : Dr. SHARADHA RAI,

PROFESSOR AND HOD OF PATHOLOGY,

KMC, MANGALORE

MEMBER SECRETARY :Dr. BHARATHI M

PROFESSOR OF PATHOLOGY,
 KVGMCH, SULLIA

MEMBERS

Dr. DINESH P V, PROFESSOR AND HOD OF COMMUNITY MEDICINE, KVGMCH

Dr. ROSHAN S D, PROFESSOR OF ORTHOPAEDICS, KVGMCH,SULLIA

Dr. SATHISH AITHAL, PROFESSOR AND HOD OF PHARMACOLOGY, KVGMCH,

SULLIA.

Dr. PRAKASH RAO, PROFESSOR OF GENERAL MEDICINE, KVGMCH, SULLIA

Dr. MAHESH BABU, ASSOCIATE PROFESSOR OF OPHTHALMOLOGY, KVGMCH,

SULLIA

Dr. SHRUTHI RAI P, ASSOCIATE PROFESSOR OF BIOCHEMISTRY, KVGMCH,

SULLIA.

Ms.VIDYA K, LECTURER-BIOSTATISTICS, KVGMCH, SULLIA.

Fr.SALEEN JOSEPH, PRIEST-PASTORAL CENTRE DIOCISE OF BELTHANGADY.

N. SANTHOSH NAIK R. CHAIRMAN, DEPARTMENT OF STUDIES IN SOCIOLOGY,

KARNATAKA STATE OPEN UNIVERSITY, MYSURU.

Mr. KRISHNAMURTHY, NOTARY ADVOCATE, SRIRAMPET, SULLIA-574327

Mrs. KRIPA A N, SOCIAL WORKER

Mrs.ASHA SURESH, LAY PERSON

DEAN,

KVG MEDICAL COLLEGE & HOSPITAL,

SULLIA.
PARTICIPANT’S INFORMATION SHEET:

I, Dr Shrikant mohan pulkantwar, Post Graduate

student in Department of Radio diagnosis am
conducting a research work for the award of M.D.
degree in Radio diagnosis.

TOPIC OF THE STUDY:

DIAGNOSTIC ACCURACY OF B-MODE, COLOR

DOPPLER, ELASTOGRAPHY WITH FNAC
CORRELATION IN EVALUATION OF CERVICAL
LYMPHADENOPATHY

AIMS AND OBJECTIVES OF THE STUDY:

Mr/Mrs _______________________________,
we are requesting you to enroll yourself in study
conducted by Dr Shrikant mohan pulkantwar , post
graduate student in M.D Radiodiagnosis under the
guidance of Dr Gowtham Gowda A G at K.V.G
Medical College Hospital, Sullia.

You have been requested to participate. During

the study you will be asked some questions and
you are supposed to answer to the best of your
knowledge.

Your participation in research is voluntary.

Your decision whether or not to participate will not
affect your relationship with K.V.G. Medical
College and hospital. If you decide not to
participate, you are free to withdraw at any time.
The purpose of this research is to assess diagnostic
efficacy of B mode, colour Doppler and
elastography in cervical lymphadenopathy
patients .

PROCEDURE INVOLVED:

If you agree to participate in this research, we

would ask your present, past and family history.
After detailed ultrasonographic examination if
positive findings are seen, a Fibroscan will be
performed.
ALTERNATIVES:

Even if you decline in participation, you will

get the routine line of management.

RISKS AND BENEFITS:

This study would be beneficial to the participants

as it would help in early detection of cervical
lymphadenopathy.

There is minimal risk involved, as elastography is a

non invasive procedure.

PRIVACY AND CONFIDENTIALITY:

The only people who know that you are a

research subject are members of the research team.
No information about you or provided by you
during the research will not be disclosed to others
without your written permission except:

1. In emergency to protect your rights and

welfare.

2. If required by law.

AUTHORIZATION TO PUBLISH RESULTS:

When the results of the research are published

or discussed, in a conference, no information will
remain confidential.

FINANCIAL INCENTIVES FOR

PARTICIPATION:

You will not be paid /offered any free gifts for

participating in the research. You will not be
reimbursed for expenses.

ಭಾಗವಹಿಸುವವರ ಮಾಹಿತಿಪತ್ರ

ವಿಕಿರಣಶಾಸ್ತ್ರ ವಿಭಾಗದಲ್ಲಿ ಸ್ನಾತಕೋತ್ತರ ಪದವೀಧರರಾದ

ಡಾ|| ಶ್ರೀಕಾಂತ್ ಮೋಹನ್ ಪುಲ್ಕಂಟವಾರ್. ಎಂ.ಡಿ ಪದವಿ

ಪಡೆಯಲು ಸಂಶೋಧನಾಕಾರ್ಯವನ್ನು ನಡೆಸುತ್ತಿದ್ದೇನೆ.

ಅಧ್ಯಯನದವಿಷಯ::ಬಿ-ಮೋಡ್, ಕಲರ್ ಡಾಪ್ಲರ್,

ಎಲಾಸ್ಟೋಗ್ರಫಿ ವಿಥ್ ಎಫ್‌ಎನ್‌ಎಸಿ ಜೊತೆಗಿನ ಕುತ್ತಿಗೆಯ

ಲಿಂಫಾಡೆನೋಪತಿಯ ಮೌಲ್ಯಮಾಪನದಲ್ಲಿ ರೋಗನಿರ್ಣಯದ
ನಿಖರತೆ

ಶ್ರೀ / ಶ್ರೀಮತಿ

____________________________________, ಡಾ

ಗೌತಮ್ ಅವರ ಮಾರ್ಗದರ್ಶನದಲ್ಲಿ

ವಿಕಿರಣಶಾಸ್ತ್ರವಿಭಾಗದಲ್ಲಿ ಸ್ನಾತಕೋತ್ತರವಿದ್ಯಾರ್ಥಿ ಡಾ||

ಶ್ರೀಕಾಂತ್ ಮೋಹನ್ ಪುಲ್ಕಂಟವಾರ್ ನಡೆಸುವ ಅಧ್ಯಯನಕ್ಕೆ

ನಮ್ಮನ್ನು ಸೇರಿಸಿಕೊಳ್ಳಬೇಕೆಂದು ನಾನು ವಿನಂತಿಸುತ್ತೇನೆ.

ಸಂಶೋಧನೆಯಲ್ಲಿ ನಿಮ್ಮಭಾಗವಹಿಸುವಿಕೆ

ಸ್ವಯಂಪ್ರೇರಿತವಾಗಿದೆ, ಭಾಗವಹಿಸಬೇಕೆ ಅಥವಾ ಬೇಡವೇ

ಎಂಬ ನಿಮ್ಮ ನಿರ್ಧಾರವು ಕೆವಿಜಿ ವೈದ್ಯಕೀಯ ಕಾಲೇಜು ಮತ್ತು

ಆಸ್ಪತ್ರೆಯಲ್ಲಿನ ನಿಮ್ಮ ಸಂಬಂಧದ ಮೇಲೆ

ಪರಿಣಾಮಬೀರುವುದಿಲ್ಲ.

ಅಧ್ಯಯನದ ಉದ್ದೇಶ-

1. ಕುತ್ತಿಗೆ ಲಿಂಫಾಡೆನೋಪತಿಯ ಮೌಲ್ಯಮಾಪನದಲ್ಲಿ ಬಿ-

ಮೋಡ್, ಕಲರ್ ಡಾಪ್ಲರ್ ಮತ್ತು ಎಲಾಸ್ಟೋಗ್ರಫಿಯ
ರೋಗನಿರ್ಣಯದ ಪರಿಣಾಮಕಾರಿತ್ವವನ್ನು

ಕಂಡುಹಿಡಿಯಲು.ಈ ಸಂಶೋಧನಾ ಅಧ್ಯಯನದಲ್ಲಿ

ಭಾಗವಹಿಸಲು ನೀವು ಒಪ್ಪಿದರೆ, ಪ್ರಶ್ನಾವಳಿಗೆ ಉತ್ತರಿಸಲು

ಮತ್ತು ವಾಡಿಕೆಯ ತನಿಖೆಗೆ ಒಳಗಾಗಲು ನಾವು ನಿಮ್ಮನ್ನು

ಕೇಳುತ್ತೇವೆ

ನೀವು ಸಂಶೋಧನಾ ವಿಷಯ ಎಂದು ತಿಳಿದುಕೊಳ್ಳುವ ಏಕೈಕ

ಜನರು ಸಂಶೋಧನಾ ತಂಡದ ಸದಸ್ಯರು, ನಿಮ್ಮ ಬಗ್ಗೆ

ಯಾವುದೇ ಮಾಹಿತಿ ಅಥವಾ ಸಂಶೋಧನೆಯ ಸಮಯದಲ್ಲಿ

ನೀವು ಒದಗಿಸಿದ ಹೊರತು ನಿಮ್ಮ ಲಿಖಿತ ಅನುಮತಿಯಿಲ್ಲದೆ

ಇತರರಿಗೆ ಬಹಿರಂಗಪಡಿಸಲಾಗುವುದಿಲ್ಲ:
1. ನಿಮ್ಮ ಹಕ್ಕುಗಳು ಮತ್ತು ಕಲ್ಯಾಣವನ್ನು ರಕ್ಷಿಸಲು

ತುರ್ತುಪರಿಸ್ಥಿತಿಯಲ್ಲಿ, ಕಾನೂನಿನ

ಅಗತ್ಯವಿದ್ದರೆ.ಫಲಿತಾಂಶಗಳನ್ನುಪ್ರಕಟಿಸಲುಅಧಿಕಾರ:

ಸಂಶೋಧನೆಯ ಫಲಿತಾಂಶಗಳನ್ನು ಪ್ರಕಟಿಸಿದಾಗ

ಅಥವಾಚರ್ಚಿಸಿದಾಗ, ಸಮ್ಮೇಳನದಲ್ಲಿ, ನಿಮ್ಮ ಗುರುತನ್ನು

ಬಹಿರಂಗಪಡಿಸುವ ಯಾವುದೇ ಮಾಹಿತಿಯನ್ನು

ಪ್ರದರ್ಶಿಸಲಾಗುವುದಿಲ್ಲ. ಈ ಅಧ್ಯಯನಕ್ಕೆ ಸಂಬಂಧಿಸಿದಂತೆ

ಪಡೆದ ಮತ್ತು ನಿಮ್ಮೊಂದಿಗೆ ಗುರುತಿಸಬಹುದಾದ ಯಾವುದೇ

ಮಾಹಿತಿಯು ಗೌಪ್ಯವಾಗಿಉಳಿಯುತ್ತದೆ.

ಭಾಗವಹಿಸುವಿಕೆಗಾಗಿ ಹಣಕಾಸಿನ ಪ್ರೋತ್ಸಾಹಗಳು

ಸಂಶೋಧನೆಯಲ್ಲಿ ಪಾಲ್ಗೊಳ್ಳಲು ನಿಮಗೆ ಯಾವುದೇ ಉಚಿತ

ಉಡುಗೊರೆಗಳನ್ನು ನೀಡಲಾಗುವುದಿಲ್ಲ / ನೀಡಲಾಗುವುದಿಲ್ಲ,

ಖರ್ಚುಗಳಿಗೆ ನಿಮಗೆ ಮರು ಪಾವತಿ ಮಾಡಲಾಗುವುದಿಲ್ಲ

ತನಿಖಾಧಿಕಾರಿಯ ಹೆಸರು: ಶ್ರೀಕಾಂತ್ ಮೋಹನ್

ಪುಲ್ಕಂಟವಾರ್ ಸಂಪರ್ಕ ವಿಳಾಸ: # 104 ,ಬಾಯ್ಸ್ ಹಾಸ್ಟೆಲ್,

ಕೆವಿಜಿ ವೈದ್ಯಕೀಯ ಕಾಲೇಜು ಮತ್ತು ಆಸ್ಪತ್ರೆ

, ಸುಳ್ಯ. ದ.ಕ

ಮೊಬೈಲ್ ಸಂಖ್ಯೆ: 7350200949

 CONSENT FORM

I, the undersigned
________________________________ have been
explained in my own vernacular language about
the study and my participation in the study is
voluntary. If I want, I can withdraw at any time.

I have been explained about the risks

involved in the procedure and have been given
enough time to clear my doubts and rights as the
study participant.

In case I have any questions related to the

study, I can contact

Dr Shrikant mohan pulkantwar (phone no

7350200949)

Signature or the left thumb print of participant or

legally authorized representative

Participant’s name: _____________________

Signature: __________________

Witness name: _____________________

Signature: __________________
Experimenter’s name: ___________________
Signature: __________________

Date: ______________

Place: _____________

ಸಮ್ಮತಿ ಪತ್ರ

ಸಂಸ್ಥೆಯ ಹೆಸರು: ಕೆವಿಜಿ ವೈದ್ಯಕೀಯ ಕಾಲೇಜು ಮತ್ತು

ಆಸ್ಪತ್ರೆ

ಪ್ರಮುಖ ತನಿಖೆದಾರರ ಹೆಸರು: ಡಾ|| ಶ್ರೀಕಾಂತ್ ಮೋಹನ್

ಪುಲ್ಕಂಟವಾರ್
ನಾನು......................................................................ನ

ನಗೆ ಅರ್ಥವಾಗುವಂತಹ ನನ್ನ ಮಾತೃಭಾಷೆಯಾದ

ಕನ್ನಡದಲ್ಲಿ ಈ ಅಧ್ಯಯನದ ಗುರಿಗಳನ್ನು, ಉದ್ದೇಶಗಳನ್ನು,

ವಿಧಾನಗಳು ಹಾಗು ಅದಕ್ಕೆ ಬೇಕಾಗುವ ಸಮಯವನ್ನು ಮತ್ತು

ಅಧ್ಯಯನದಲ್ಲಿ ಪಾಲ್ಗೊಳ್ಳುವುದರಿಂದ ಆಗುವ

ಪ್ರಯೋಜನಗಳು ಅಥವಾ ಇರುಸುಮುರುಸುಗಳನ್ನು

ತನಿಖೆದಾರರು ವಿವರಿಸಿರುತ್ತಾರೆ. ಈ ಅಧ್ಯಯನವು ಒಂದು

ಸಂಶೋಧನೆಯ ವಿಧಾನವಾಗಿದ್ದು ಇದರಲ್ಲಿ ನನ್ನ

ಭಾಗವಹಿಸುವಿಕೆ ಸ್ವಯಂಪ್ರೇರಿತವಾಗಿದ್ದು ಹಾಗೂ ನಾನು

ಯಾವುದೇ ಸಮಯದಲ್ಲಿ ನನ್ನ ಇಷ್ಟಕ್ಕೆ ಅನುಗುಣವಾಗಿ

ಯಾವದೇ ರೀತಿಯಾದಂಥಹ ದಂಡವಿಲ್ಲದೆ, ಅಥವಾ

ಪ್ರಯೋಜನಗಳನ್ನು ಕಳೆದುಕೊಳ್ಳದೆ, ಅಥವಾ ಕಾರಣವನ್ನು

ತಿಳಿಸದೇ ಈ ಅಧ್ಯನದಿಂದ ಹೊರನಡೆಯುವ ಹಕ್ಕನ್ನು

ಹೊಂದಿರುತ್ತೇನೆ ಹಾಗೂ ಈ ಅಧ್ಯನದಲ್ಲಿ ಪಾಲ್ಗೊಳ್ಳುವ ಅಥವಾ

ಹೊರನಡೆಯುವ ಹಕ್ಕು ಯಾವುದೇ ಹಂತದಲ್ಲಿ ನನ್ನ ಹಕ್ಕುಗಳು

ಮತ್ತು ಯೋಗಕ್ಷೇಮದ ಮೇಲೆ ಕೇಡನ್ನು ಬೀರುವುದಿಲ್ಲವೆಂದು

ನನಗೆತಿಳಿಸಿರುತ್ತಾರೆ. ಈ ವಿಚಾರವನ್ನು ಗೌಪ್ಯವಾಗಿ

ಇಟ್ಟಿರುತ್ತಾರೆ ಹಾಗೂ ಶೈಕ್ಷಣಿಕ ಉದ್ದೇಶಗಳಿಗೆ ಮಾತ್ರ

ಬಳಸುತ್ತಾರೆ ಎಂದು ನನಗೆ ಆಶ್ವಾಸನೆ ನೀಡಿರುತ್ತಾರೆ. ಈ

ಮೂಲಕ ಇಲ್ಲಿ ಉಲ್ಲೇಖಿಸಿರುವಂಥಹ ಅಧ್ಯಯನದಲ್ಲಿ

 ಪಾಲ್ಗೊಳ್ಳಲು ನಾನು ಸಮ್ಮತಿ ನೀಡಿರುತ್ತೇನೆ. ನಾನು

ಬಯಸಿದಲ್ಲಿ ಮುಂದೊಂದು ದಿನ ಈ ಸಮ್ಮತಿಯನ್ನು

ಹಿಂತೆಗೆದುಕೊಳ್ಳಬಹುದು ಎಂಬುದನ್ನು ನಾನು ಅರಿತಿರುತ್ತೇನೆ.

ಈ ಸಮ್ಮತಿ ಪತ್ರಕ್ಕೆ ಸ್ವಯಂ ಪ್ರೇರಿತವಾಗಿ ಸಹಿ ಹಾಕುವ

ಮೂಲಕ ಈ ಅಧ್ಯನದಲ್ಲಿ ಪಾಲ್ಗೊಳ್ಳುವ ಒಪ್ಪುಗೆಯನ್ನು ನಾನು

ಸೂಚಿಸುತ್ತೇನೆ. ನನಗೆ ಈ ಅಧ್ಯಯನದ ಕುರಿತಾಗಿ ಯಾವುದೇ

ಸಂಶಯಗಳು /ಪ್ರಶ್ನೆಗಳು ಇದ್ದಲ್ಲಿ ಈ ಕೆಳಕಂಡ ವ್ಯಕ್ತಿಯನ್ನು

ಸಂಪರ್ಕಿಸುತ್ತೇನೆ.

ಡಾ|| ಶ್ರೀಕಾಂತ್ ಮೋಹನ್ ಪುಲ್ಕಂಟವಾರ್ ಮೊಬೈಲ್

ನಂ:7350200949

ಪಾಲ್ಗೊಳುವವರಹೆಸರು: ಸಾಕ್ಷಿಧಾರರಹೆಸರು:

ಸಹಿ:

ಸಹಿ:

ದಿನಾಂಕ:

ದಿನಾಂಕ:

ಸ್ಥಳ:

ಸ್ಥಳ:
CASE RECORD PROFORMA
Section1. IDENTIFICATION DATA:
Age:
Date:
Sex:
Occupation:
Registration:

Section2. HISTORY
Chief complaints:
Past history:
General examination:
Systemic examination:
Local examination:

Section3. INVESTIGATIONS
USG, Doppler, Elastography findings
FNAC findings:

Section4:FOLLOW UP

GNATT CHART: