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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE, KARNATAKA
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.
NAME OF THE CANDIDATE
AND ADDRESS
(IN BLOCK LETTERS)
DR. ANINDYA SUNDAR DAS
POST GRADUATE STUDENT,
DEPARTMENT OF ORAL MEDICINE AND
RADIOLOGY,
BANGALORE INSTITUTE OF DENTAL
SCIENCES AND HOSPITAL.
5/3, HOSUR ROAD,
BANGALORE-560 029.
2.
NAME OF THE INSTITUTION
BANGALORE INSTITUTE OF DENTAL
SCIENCES AND HOSPITAL AND POST
GRADUATE
RESEARCH
CENTRE,
BANGALORE - 560 029.
3.
COURSE OF THE STUDY
AND SUBJECT
MASTER OF DENTAL SURGERY(MDS),
ORAL MEDICINE AND RADIOLOGY
4.
DATE OF ADMISSION TO
COURSE
JUNE 2012
5.
TITLE OF THE TOPIC
“Ultrasound Elastography Evaluation of
Salivary Glands – in Patients Undergoing
Radiotherapy
of
Head
And
Neck
Malignancy.”
6.
BRIEF RESUME OF INTENDED WORK:
6.1 NEED FOR STUDY
Radiotherapy is one of the major treatment modality in head & neck malignancies
The most important complication of head and neck radiotherapy is the changes in the
salivary glands in the field of radiation therapy. These effects lead to parenchymal and
vascular changes within the gland which in turn alters the volume and viscosity of the
salivary secretion through the affected gland. There are several changes happen in tissues
located within the radiation field after radiotherapy which can be evaluated by clinically
sialometry, sialochemistry and various imaging modalities, like CT scan, MRI and
Ultrasonography. Sialometry and sialochemistry, they can give only functional status, but
does not give the morphological characteristics of salivary gland, such as size, shape,
elasticity, blood flow and nature of the parenchymal tissue changes which can be obtained by
Ultrasonography.
Earlier, conventional Elastography was the technique employed to study the physical
properties of soft tissue details. However this technique is operator dependant & evaluates
the soft tissue with less reproducibility and with relative qualitative assessment, whereas
now ARFI Elastography is a modern advancement, which is non invasive and uses accurate
method to assess quantitative estimation of elastic changes in the soft tissues using acoustic
force impulses or push pulse technique.
Review of literature on the ultrasound evaluation of salivary glands during
radiotherapy has shown very limited studies and no study so far done using ARFI
elastography. Hence a study was designed to assess the morphological changes of salivary
glands during radiation therapy using ARFI elastography.
6.2 REVIEW OF LITERATURE:
1. This study1 was conducted on 20 patients who were undergoing radiotherapy in head
& neck malignancy . The parotid & submandibular glands were present under that
radiation field. Glands were evaluated before and during radiotherapy. A significant
differences in length , height , depth and also echotexture, echogenicity and gland
margins were observed before and after radiotherapy.
2. In this study2 Doppler ultrasound was used to assess the haemodynamic condition of
the salivary glands.The amount of radiation dosage was co-relate with the ultrasound
radiographic changes of the 18nasopharyngeal carcinoma patients. The results showed
that the post-RT salivary glands were significantly smaller to the pre-RT ones and also
demonstrated lower vascular velocity, resistive & pulsatility.
3. The aim of this study3 was to establish the elasticity values of various normal tissues
like thyroid, liver, spleen, parotid & submandibular salivary glands etc by using shearwave ultrasound elastography which was a relatively new technique employed..The
results showed that the normal elasticity values of various tissues obtained in
kilopascals was found to be very useful to determine the normal & pathological tissues.
4. The aim of this study4 was to measure changes in the salivary flow rate in head &
neck cancer following accelerated radiotherapy & concurrent chemotherapy in the
disease free period of one year following treatment. The results showed a significant
reduction in flow rate which decreased further till the six months and a recovery
following 12 months of the study.
5. In this study5 the new advancement of ultrasound technique acoustic radiation force
impulse (ARFI) imaging or elastography technique was used to evaluate an improved
visualization of parotid tumours. Result of this study showed that elastography imaging
can be differentiate into various pathological masses of parotid gland, and also can be
differentiate between normal and pathologic condition of the glands.
6.3 OBJECTIVE OF THE STUDY
7.

To study the ARFI Elastography changes of salivary glands in head & neck
malignancy patients undergoing radiotherapy.

To co-relate the morphological changes of the salivary glands with the salivary flow
rate.
MATERIALS AND METHODS
7.1 Source of data

Patients of head and neck cancers visiting the Department of Radiotherapy at the
Bangalore Institute of Oncology, Bangalore.
Inclusion criteria:
1) Patients having normal morphological parotid and submandibular glands in the field of
radiotherapy for any head and neck cancers.
2) Patients receiving bilateral radiotherapy with salivary glands in the radiation filed with
the radiation dose of 50grays.
3) All patients undergoing external beam therapy.
Exclusion criteria:
1) Patients with the presence of salivary glands diseases such as Sjogren’s disease, salivary
gland masses ,viral and bacterial diseases etc.
2) Patients with history of previous radiotherapy or surgical procedure in the gland region.
3) Systemic diseases like diabetes, hypertension, renal diseases etc
4) Patients who are on medications.
MATERIALS USED:
Elastography Machine:1. Siemen Acuson S 2000
2. Linear probe of frequency 9-14 MHz
3. Linear matrix probe of frequency 4-9 MHz

Graduated test tube to measure whole saliva.

Stimulant for saliva secretion.

Funnel to collect the saliva.
7.2 METHODS OF COLLECTION OF
PROCEDURES, IF ANY
DATA
(INCLUDING
SAMPLING
A total of 20 patients(20x4glands=80glands)will be selected randomly for the study,
during the period of 2012-2015.from the department of radiotherapy fulfilling all the
inclusion and exclusion criteria. Patients with head and neck cancers receiving radiotherapy
in the field of salivary glands, will be assessed for the evaluation of salivary gland changes
using Ultrasound Elastography Detailed case history of the patient regarding the type of
cancer, total dosage/fraction clinical and salivary gland examination will be done & recorded
in a proforma.
Ultrasonographic evaluation prior to radiotherapy will be done to evaluate the
morphology of salivary gland in the field of radiotherapy. The same patients will be further
evaluated during 2nd and 6th week of radiotherapy to assess the morphological changes in the
gland. To co-relate the ultrasonographic changes with salivary flow rate changes, salivary
flowmetry will be done simultaneously during each ultrasonographic assessment.
All patients unstimulated & stimulated saliva will be taken in a standardized time in a day
between 10am and 12 noon, at least 1hour after breakfast.
Unstimulated saliva collection
The patient will be made to seat and bent slightly forward. The patient will be asked to split
into the saliva collecting funnel which will be connected into the graduated test tube.
Stimulated saliva collection:-
First the patient is asked to clear the mouth by swallowing the residual saliva and then
instruction will be given to chew the piece of paraffin wax for 30seconds to stimulate the
salivary flow.
After 30 seconds the patient is asked to expectorate in to the spitton , further continuation of
chewing for a 5minutes will be done and the stimulated saliva will be collected at regular
intervals in that graduated test tube.
The findings of the morphological changes of the salivary glands from ARFI
Ultrasonography will be compared with the salivary flow changes using statistical
analysis.There are two types of variants which will be used in this study they are
Scores(paired ‘t’test) & Categorical(Mc Nemar’s test)tests.
7.3 Does the study require any investigations or interventions to be conducted on
patients or both humans or animals? If so, please describe briefly.
Yes
7.4 Has ethical clearance been obtained from your institute in case of 7.3?
Yes
8.
LIST OF REFERENCES:
1. M Imanimoghaddam, M Rahrooh, Z Tafakhori, S Zahedanaraki and F
Homaeieshandiz. “Changes of parotid and submandibular glands caused by
radiotherapy – An Ultrasound Evaluation”, Dentomaxillofacial
Radiology.2012;41:379–384.
2. V W C WU, PhD, M T C YING, PhD and D L W KWONG, “Evaluation of
radiation-induced changes to parotid glands,” The British Journal of Radiology. 2011;
84:843-849.
3. Kemal Arda,Nazan Ciledag,Elif Aktas,Bilgin Kadri Arıbas,Kenan Köse,
“Quantitative Assessment of Normal Soft-Tissue Elasticity,” . AJR .2011; 197.
4. Punita
lal,Ranjeet
Bajpai,Rohini
khurana,K.J.Maria
das,Prabhat
kumar,Anu
Tiwari,Neha Gupta,Shaleen kumar, “Changes in salivary flow rates in head and neck
cancer after chemoradiotherapy,” Journal of Cancer Research and Therapeutics. 2010;
6(4).
5. Andreas Knopfa, Naglaa Mansoura, Konrad Stockb, “Application of contrast –
enhanced ultrasound and acoustic radiation force impulse imaging in parotid gland
lesion,” European Journal of Radiology, 2011; 78(Extra): e115–e118.
9.
SIGNATURE OF CANDIDATE
10.
REMARKS OF THE GUIDE
11.
NAME AND DESIGNATION OF
(IN BLOCK LETTERS)
11.1 GUIDE
DR. JAYANTHI.K
PROFESSOR & H.O.D.
DEPARTMENT OF ORAL MEDICINE
AND RADIOLOGY
BANGALORE INSTITUTE OF DENTAL
SCIENCES AND HOSPITAL,
BANGALORE – 560 029.
11.2 SIGNATURE
11.3 CO-GUIDE
DR.SUDHAKAR
H.O.D
DEPARTMENT OF RADIOLOGY
(ULTRASONOGRAPHY)
BANGALORE INSTITUTE OF
ONCOLOGY,
BANGALORE-560 027
11.4 SIGNATURE
11.5 HEAD OF THE
DEPARTMENT
11.6 SIGNATURE
DR. JAYANTHI.K
PROFESSOR & H.O.D.
DEPARTMENT OF ORAL MEDICINE
AND RADIOLOGY
BANGALORE INSTITUTE OF DENTAL
SCIENCES AND HOSPITAL,
BANGALORE – 560 029.
12.
12.1 REMARKS OF THE
CHAIRMAN AND
PRINCIPLE
12.2 SIGNATURE
DR.VINAYA S. PAI
PRINCIPAL,
BANGALORE INSTITUTE OF DENTAL
SCIENCES AND HOSPITAL,
BANGALORE – 560 029.