AN1-V1/SGSOP 03/V1

Project Submission Form for Review by IEC

(6 copies and a CD required)
A. Identification details:
*IEC Code No. ( To be filled by the Bioethics cell):
Study/Protocol No.(For drug/device trials/any other, to be filled by PI):

Type of project: Intramural [ ] Extramural [ ] Drug trial/devise [ ]

Independent [√ ] MD/DM/MCh/PhD/SRF Project [√ ]
Collaborative [ ] Other [ ]

Status of review: New [√ ] Revised [ ]

Proposal Title: “Prospective Randomized Controlled Study Comparing the Diagnostic

Yield and specimen adequacy of Flex 19G EBUS-TBNA Needles and 22G EBUS-FNB
device for the evaluation of mediastinal and hilar lymphadenopathy”

B. Investigator details:
Name, Designation & Qualifications Departmental Tel Nos. & Signature
Email ID
**PI Dr. Ajmal Khan [email protected]
Additional Professor, Pulmonary Medicine 8765974030
SGPGIMS, Lucknow
Co- Dr. Alok Nath [email protected]
investigator 1 Professor, Pulmonary Medicine 8004904532
SGPGIMS, Lucknow
Co- Dr. Zia Hashim [email protected]
investigator 2 Additional Professor, Pulmonary Medicine 8004904533
SGPGIMS, Lucknow
Co- Dr. Vinita Agarwal
investigator 3 Professor,
Department of Pathology, 8004904561
SGPGIMS
**One page recent, signed and dated curriculum vitae of the investigators indicating qualifications and relevant
experience for new or investigator outside SGPGI or of the student (MD/MS/DM/MCh/PhD) who has submitted
thesis/project
C. Sponsor Information: Applicable [ ] Not applicable [√ ]
1. Name of sponsor/CRO:

2. Indian: a) Government  Central  State  Institutional 

b) Private 

3. International: Government  Private  UN Agencies 

4. Industry: National  Multinational 

5. Contact address of sponsor/CRO:

6. Budget: Rs.__ ___________________

7. Details of allocation of budget in Clinical Trial Agreement: Yes [ ] No [ ]

D. Study related Information:

1. Design of study:
Epidemiological  Basic Sciences  Behavioral 
Clinical  Interventional  Single Centre 
Multicenter 
2. No. of participants: SGPGI Total (if multicentre)
Patient* _75 + 75_
Control* _________
3. Duration of study: __1___ years___
4. Duration of subject participation (no. of visit by a participant in study):_________
*Please mention sample size calculation and source of control in methodology
E. Interventional study: Yes [ ] No [√ ] If No, move to next section i.e. F
1. Does the study involve use of
Drugs  Devices  Vaccines  Radiopharmaceutical 
Recombinant DNA/Gene therapy  Stem cell  (need BARC approval)
(need DBT-GEAC approval/NAC-SCRT registration and approval)
Indian Systems of Medicines/ Alternate systems of Medicine 
Any Other  None 

2. Is it approved and marketed

In India  UK & Europe  USA  Other Countries, Specify_______
3. Does it involve a change in use, dosage, route of administration? Yes  No 
If yes, whether DCGI’s/Any other Regulatory Authority’s Permission is obtained?
Yes  No 
If yes, copy of permission attached. Yes  No 

4. Is it an Investigational New Drug? Yes  No 

If yes
a. Investigator’s Brochure enclosed Yes  No 
b. Preclinical studies data available (If yes, provide summary) Yes  No 
c. Clinical studies data available (If yes, provide summary) Yes  No 
d. Clinical study is: Phase I  Phase II  Phase III  Phase IV  NA 
If phase I-III will the drug/device be provided free Yes  No 
If phase IV will the drug/device be provided at cost less than Hospital pharmacy?
Yes  No 
e. DCGI’s permission obtained Yes  No 
If yes, copy of letter enclosed Yes  No 
5. Data monitoring
a. Is there a plan for reporting of adverse events? Yes  No 
If yes, reporting will be done to Sponsor  IEC 
Is there a plan for interim analysis of data? Yes  No 

6. Provision for travel/treatment due to injury out of study Yes  No 

If yes, by Sponsor  Investigator  Insurance Company  Any Other 
7. Registered with Clinical Trial Registry – India Yes No 
If yes copy of certificate enclosed Yes  No 

F. Details of participant of study:

1. Will subjects from both sexes be recruited: Yes [√ ] No [ ]
2. Inclusion/exclusion criteria given: Yes [√ ] No [ ]
3. Type of subjects: Volunteers [ ] Patients [√ ]
4. Vulnerable subjects Yes [ ] No [√ ]
( if Yes tick the appropriate boxes)
Pregnant Women [ ] Children [ ] Elderly [ ] Fetus [ ]
Illiterate[ ]Handicapped [ ] Terminally ill [ ] Seriously ill [ ]
Mentally challenged [ ] Economically & socially backward [ ] Any other [ ]
5. Special group subjects: Yes [ ] No [√ ]
( if Yes tick the appropriate boxes)
Captives [ ] Institutionalized [ ] Employees [ ] Students [ ]
Nurses/Dependent [ ] Staff [ ] Armed Forces [ ] Any Other [ ]

G. Privacy and confidentiality:

1. Study Involves Direct Identifiers (Pt. identified by name/Cr. no.) 
Indirect Identifiers/Coded (Pt. identified after break of code) 
Completely Anonymized /Delinked (Pt. cannot identified) 
2. Confidential handling of data by staff Yes  No 
3.

H. Detail of sample collection (If no sample being collected, move to next section i.e. I):
A. Regarding sample collection
1. Collection of organs or body fluids or blood. If yes, please specify Yes  No 
Type:___Mediastinal Lymph Node Aspirate______________
Amount each time___3____Aspirate Pieces Total____3____ Biopsy Pieces
2. No. of time in 2 week_____1______ Total (in 2 weeks)_____ ____
3. Collection of fetal tissue or abortus. If yes, please specify Yes  No 
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
4. Use of pre-existing/stored/left over samples. If yes, please specify Yes  No 
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
5. Proper disposal of material Yes  No 
B. Special situation
1. Will any sample collected from the patients be sent abroad? Yes  No 
If yes, give details and address of collaborators
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
a. Sample will be sent abroad because (Tick appropriate box)
Facility not available in India 
Facility in India inaccessible 
Facility available but not being accessed 
If so, reasons___________________________________________________________________
b. Has necessary clearance been obtained Yes  No 
2. Collection for banking/future research Yes  No 

I. Participant Information Document (PID) and Consent Form:

1. Consent *Written  Oral  Audio-Visual 
Patient Information documents and consent form attached : (Tick the included elements)
Understandable language  Alternatives to participation 
Statement that study involves research  Confidentiality of records 
Sponsor of study  Contact information 
Purpose and procedures  Statement that consent is voluntary 
Risks & discomforts  Right to withdraw 
Benefits  Benefits if any on future 
Consent for future use of material biological 
Free supply of drug till it is not marketed in country if necessary 
Compensation for study related injury 
Translation of Participant Information Document (PID) in local Language 
2. If healthy volunteers, PID for them Yes  No 
3. If participant is child, PID for parent Yes  No 
4. PID and Assent Form for child 8-18 yrs Yes  No 
Consent form in English  Local Languages 
5. (For participant/ parent/legal guardian)
Who will obtain consent? PI-Co-PI  Nurse/Counselor 
Research Staff  Any Other 
*If written consent is not obtained, give reasons……………………………………………...

J. Will any advertising be done for recruitment of Subjects? Yes  No 

(Posters, flyers, brochure, websites – if so attach a copy)

K. For archival of record by Bioethics cell for more Yes  No  Not applicable 
than 5 years required
If yes, for how many years………………………
L. Risk and benefits:
1. Is there physical/social/psychological risk/discomfort? Yes  No 
If yes, Minimal or no risk 
More than minimum risk 
High risk 
2. Is there benefit a) to the subject? Yes  No 
Direct  Indirect 
b) to the society Yes  No 
3. Do you think that the risk is in commensurate with the benefits to be accrued
subjects/community/country? Yes  No 
4. Please identify the ethical issues involved in your study.________________________
Mediastinal lymph node aspiration was traditionally done through blind transbronchial
needle aspiration with low yield and possibility of complication like inadvertent puncture
of blood vessels. With the introduction of endobronchial ultrasound, the lymph node
aspiration has become easy as it is done under real time visualization thus reducing the
complications and increasing the yield. EBUS-TBNA can be performed by needles
ranging from 19 to 25 gauges including 22 gauge fine needle biopsy. There is no head-to-
head study comparing the yield of 19G FNA Needle vs 22 G FNB needle despite the
presence of both needle for long time. In our department mediastinal lymph node
aspiration is routinely performed using both the needle in the routine patient care with no
particular preference to any gauge needle. So far which needle will be used in particular
patient was dependent on the availability of the needle. Randomized study is designed to
know the utility of both needles in comparison to each other.

M. Do you have conflict of interest? Yes  No 

(Financial/Non financial)
If yes, specify________________________________________________________________
N. Brief proposal summary
Aim(s) and objectives: Assessment of mediastinal lymph nodes and masses is crucial to
establish the etiological diagnosis as well as staging in patients with lung cancer. EBUS guided
TBNA has emerged as rapid and minimally invasive technique to visualize the lymph nodes
beyond the tracheal or bronchial wall and real time sampling of the mediastinal and hilar lymph
nodes.1 For the evaluation of mediastinal lymphadenopathy, EBUS-TBNA is superior to
conventional TBNA and almost equivalent in diagnostic yield with mediastinoscopy. EBUS-
TBNA has good diagnostic yield and safety profile for obtaining adequate cytological and
histologic samples which is also suitable for assessment for immunohistochemistry and driver
mutation.2 Factors necessary to acquire satisfactory specimen to establish the diagnosis with
minimum complications includes the number of samples and needle passes per lymph node, size
of the needle and rapid onsite evaluation.3-5 Among these, the size variation of the needle have
been extensively studied, however majority of the studies including a meta-analysis showed no
difference in the diagnostic yield or the sample adequacy.1,2,4,6-12 Traditionally, EBUS-TBNA is
performed using either 21 G or 22 G needle with a major limitation of inadequate sample
especially when histologic assessment of tissue architecture is necessary such as in lympho-
proliferative disorders and granulomatous inflammation.13,14 Although, the specimen obtained
with larger bore 19 G needle has been shown to be superior in terms of more cellular material
and ability to subclassify malignant disease, it has more hemorrhagic samples.8,15-17 Recently a
novel 22 G fine needle biopsy device (EBUS-FNB) (Acquire FNB device, Boston Scientific Co.,
Natick, MA) has been introduced for endobronchial use after an experience gained from
gastroenterology endoscopic ultrasound reporting high yield for core biopsies.18,19 FNB device
has a unique design with 3 symmetrical, fully formed, cutting heels with 3 angled points to
provide acquisition of FNB specimen in the form of a core tissue which might improve the
overall diagnostic yield. Herein, we will study in a randomize fashion to compare the diagnostic
yield and specimen adequacy of the 22G EBUS-FNB needle and 19 G EBUS-FNA needle in the
evaluation of mediastinal and hilar lymphadenopathy. We hypothesize that the FNB needle
would have a higher diagnostic sensitivity due to the acquisition of a better tissue specimen.
__________________________
Signature of PI
Name_____Dr. Ajmal Khan__ Date__10th February 2022____
Detail Study / Project Protocol
Significance and rationale of study:
Conventional TBNA is performed based on landmark location of the lymph nodes within
the airway and the needle is passed blindly at the target as a result the diagnostic yield is low.
EBUS guided TBNA has emerged as rapid and minimally invasive technique to visualize the
lymph nodes beyond the tracheal or bronchial wall and real time sampling of the mediastinal and
hilar lymph nodes. For the evaluation of mediastinal lymphadenopathy, EBUS-TBNA is superior
to conventional TBNA and almost equivalent in diagnostic yield with mediastinoscopy. EBUS-
TBNA has good diagnostic yield and safety profile for obtaining adequate cytological and
histologic samples which is also suitable for assessment for immunohistochemistry and driver
mutation. Technically standard needle can influence results and larger gauge needles can obtain
satisfactory sample volumes with higher diagnostic yield. To obtain cytology specimens, 20-
gauge to 25-gauge needles are usually used, whereas 19-gauge needles are needed to obtain a
large tissue for histology and mutational analysis. Although the specimen obtained with larger
bore 19 G needle has been shown to be superior in terms of more cellular material, ability to
subclassify malignant disease, and for mutation analysis which is required for target therapy,
however the size of the 19 G needle may lead to a higher degree of tissue trauma or a larger
amount of aspirated blood, each of which can alter the diagnostic yield and cellularity of the
sample.
Recently a novel 22 G fine needle biopsy device (EBUS-FNB) (Acquire FNB device,
Boston Scientific Co., Natick, MA) has been introduced for endobronchial use after an
experience gained from gastroenterology endoscopic ultrasound (EUS) guided biopsy from
pancreatic head which showed high yield for core biopsies. When compared with FNA, the fine-
needle biopsy (FNB) samples obtained with 22G FNB device were histologically superior, and
required fewer passes. Sample obtained with FNB device was also suitable for
immunohistochemistry and driver mutation analysis which is important for target therapy . FNB
device has a unique design with 3 symmetrical, fully formed, cutting heels with 3 angled points
to provide acquisition of FNB specimen in the form of a core tissue which might improve the
overall diagnostic yield. We hypothesize that the FNB device would have a higher diagnostic
sensitivity than 19G EBUS-FNA needle due to the acquisition of a better tissue specimen with
lesser degree of tissue trauma and low amount of aspirated blood which will increase the
diagnostic yield.
Relevance and expected outcome of the study:
Main objective is to determine whether the size of needle influences the diagnostic yield
of EBUS-TBNA, its complication rates and patient tolerance. Smaller gauge is theoretically
should be of low yield but due to more maneuverability of the needle it is able to reach the area
untouched by the larger needle. Lack of uniform procedural guidelines for the preference of size
of needle further complicates the decision regarding needle size selection. Herein, we will
evaluate the diagnostic yield and safety of the 22G EBUS-FNB needle with 19 G EBUS-FNA
needle in the evaluation of mediastinal and hilar lymphadenopathy. We hypothesize that the FNB
needle would have a higher diagnostic sensitivity due to the acquisition of a better tissue
specimen.

Preliminary work done so far

Up to our best of knowledge, there is no prospective randomized controlled study has been done
so far, which has evaluated the diagnostic yield and sample adequacy of 19G EBUS-FNA needle
and 22G FNB device. In our department, we have used 22G FNB device in few cases of
mediastinal and hilar lymphadenopathy and got a satisfactory result in term of diagnostic yield
and sample adequacy. Although we got satisfactory result but superiority of 22G FNB device
cannot be established without any randomized control trial, so we have planned a randomized
controlled study to evaluate the diagnostic yield and sample adequacy of 19G EBUS-FNA
needle and 22G FNB device.

Methodology:
All examinations will be on an outpatient basis under local anaesthesia with mild
conscious sedation. Midazolam and Fentanyl are given to the patient intravenously before the
start of the examination under direct supervision of trained anaesthetist. If patient donot tolerate
bronchoscopic procedure even after conscious sedation with midazolam and fentanyl , than the
whole procedure will be done under the general anesthesia under the supervision of anaesthetist.
All Bronchoscopic procedure will be done done by the faculty of pulmonary medicine
department. The bronchoscope will be inserted orally, and a 2-mL bolus dose of 1% lidocaine
will be splayed from the larynx to the airway through the instrument channel during the
procedure. Electrocardiogram, pulse oximetry, and blood pressure monitoring will be done
throughout the whole procedure.
Once the bronchoscope is introduced into the airway and after reaching the desired position the
balloon is inflated with saline to provide an ultrasonic transparent fluid coupling medium to
achieve a maximum contact with the tissue of interest. For optimal imaging, 0.5 mL of saline
will be pushed into the balloon for mediastinal lymph nodes and 0.3 mL for hilar lymph nodes.
Using EBUS, a lymph node survey will be performed in all patients at the beginning of
the procedure to identify the largest and most accessible lymph node station. Ultrasonically
visible vascular landmarks will be used to identify the specific lymph node stations according to
the new International Association for the Study of Lung Cancer lymph node map. Color Doppler
mode was used to exclude intervening vessels immediately before needle puncture. The lymph
node station, size, number, and the ultrasound characteristics of each lymph node will be
recorded. After localizing the lymph node to be sampled, TBNA needle fastened to the working
channel of the bronchoscope. The sheath adjuster knob is loosened, and the length of the sheath
is adjusted so that the sheath can be visualized on endoscopic image. After unlocking the needle
adjuster, under real-time ultrasonic guidance, the needle will be placed within the lesion. A stylet
will be used to prevent plugging of the bronchial wall and will move back and forth within the
needle to remove any bronchial mucosal plug. After withdrawal of the stylet, suction will be
applied using a syringe, and the needle will be moved back and forth ( at least 10 to 20 times)
inside the lesion obtaining the longest needle strokes possible. After withdrawal of the TBNA
needle, the stylet will be inserted into the TBNA needle to push out the aspirated specimen on
the filter paper for histology. The stylet will be then removed and residual aspirates will be
blown onto glass slides using air through a syringe, and then fixed in 95% ethanol for cytology.
Rapid onsite evaluation (ROSE) will be done by the pathologist to check for the adequacy of the
sample.

Study setting:
This will be investigator initiated prospective randomized controlled study and will be
carried out on the patients scheduled for routine EBUS-TBNA from the OPD of the department
of pulmonary medicine at SGPGIMS Written informed consent will be obtained from the patient
prior to the enrollment in the study.

Specific Objectives:
Work plan methodology:
This prospective randomized controlled study of EBUS-TBNA will be performed using 19-
gauge needle vs 22-gauge FNB needle with a 1:1 computer-generated randomization.

Primary Objective
To determine the diagnostic yield/performance and histologic yield of 22G acquire
needle and 19 G conventional EBUS needle.
Diagnostic yield is defined as the percentage of patients biopsied in which a definitive
diagnosis can be made after combined analysis of clinical ,radiological and histopathologic
finding
Histologic yield is defined as the percentage of patients biopsied in which a definitive
diagnosis cannot be made after combined analysis of clinical ,radiological and histopathologic
findings although biopsy sample is adequate according to below mentioned criteria.

Secondary Objective
1. The proportion of subjects with adequate sample.
2. Ability of FNB device to acquire core biopsy
3. The incidence of adverse events (including endobronchial bleeding, pneumothorax,
hypoxemia, mediastinitis)

The sample will be taken as adequate, if the aspirate fulfill the following requirement :-
For 19 G Standard EBUS needle
1. More than 5 low power fields showed 100 lymphocytes per field, or
2. Anthracotic pigment-laden macrophages are present , or
3. Abnormal findings such as granulomas or malignant cells are seen
For 22g FNB Device
1. More than 5 low power fields showed 100 lymphocytes per field , or
2. Anthracotic pigment-laden macrophages are present , or
3. Abnormal findings such as granulomas or malignant cells are seen
4. “Core sample” is defined as the presence of cohesive/intact tissue microscopically
holding the form of the needle chamber, confirmed by pathologist during rapid onsite
evaluation (ROSE)

Inclusion criteria:
All consecutive patients attending the OPD of pulmonary medicine department at SGPGI and
fulfilling the following requirement:-
a) Age > 18 years
b) Radiographic features of mediastinal or hilar lymphadenopathy
c) Patient receiving anticoagulant/antiplatelet will be included in study only after taking
consultation from their parent department regarding the transient discontinuation of
antiplatelet and anticoagulant before the procedure.

Exclusion criteria:
a) Hypoxemic patient (SpO2 < 94 at room air)
b) Patients having known bleeding diathesis
c) Patients with poor cardiopulmonary reserve or marked hypoxemia at rest
d) Accessibility of more convenient site to establish the diagnosis

Sample size:
This study is investigator-initiated pilot project. No such study had been done in the past ,
so sample size calculation is not desirable ,although we would include all the patient fulfilling
the inclusion criteria ,attending the Pulmonary medicine OPD in the coming one and half year.

Statistical analysis
Computer software Microsoft excel will be used for data recording. The results for each
group will be compared using SPSS version 16.0 (SPSS Inc.,Chicago, IL, USA). Summary
statistics will be used to describe the study population in each group. Pearson’s chi-squared test
(or Fisher’s exact test) and McNamer test (or Wilcoxon’s rank-sum test) will be used to
determine the significance of differences between the study groups. A p-value of ＜0.05 will be
considered significant. Results will be calculated using an intent-treat-analysis.
Reference
1. Yarmus LB, Akulian J, Lechtzin N, et al. Comparison of 21-gauge and 22-gauge aspiration
needle in endobronchial ultrasound-guided transbronchial needle aspiration: results of the
American College of Chest Physicians Quality Improvement Registry, Education, and Evaluation
Registry. Chest. 2013;143(4):1036-1043.
2. Giri S, Pathak R, Yarlagadda V, Karmacharya P, Aryal MR, Martin MG. Meta-analysis of 21-
versus 22-G aspiration needle during endobronchial ultrasound-guided transbronchial needle
aspiration. J Bronchology Interv Pulmonol. 2015;22(2):107-113.
3. Sun J, Yang H, Teng J, et al. Determining factors in diagnosing pulmonary sarcoidosis by
endobronchial ultrasound-guided transbronchial needle aspiration. Ann Thorac Surg.
2015;99(2):441-445.
4. Biswas A, Wynne JP, Patel D, Weber M, Thakur S, Sriram PS. Comparison of the yield of 19-G
eXcelon core needle to a 21-G EBUS needle during endobronchial ultrasound guided
transbronchial needle aspiration of mediastinal lymph nodes for the detection of granulomas in
cases of suspected sarcoidosis. J Thorac Dis. 2017;9(9):E864-e866.
5. Oki M, Saka H, Ando M, et al. How Many Passes Are Needed for Endobronchial Ultrasound-
Guided Transbronchial Needle Aspiration for Sarcoidosis? A Prospective Multicenter Study.
Respiration. 2018;95(4):251-257.
6. Chaddha U, Ronaghi R, Elatre W, Chang CF, Mahdavi R. Comparison of Sample Adequacy and
Diagnostic Yield of 19- and 22-G EBUS-TBNA Needles. J Bronchology Interv Pulmonol.
2018;25(4):264-268.
7. Dhooria S, Sehgal IS, Prasad KT, et al. Diagnostic yield and safety of the ProCore versus the
standard EBUS-TBNA needle in subjects with suspected sarcoidosis. Expert Rev Med Devices.
2021;18(2):211-216.
8. Dooms C, Vander Borght S, Yserbyt J, et al. A Randomized Clinical Trial of Flex 19G Needles
versus 22G Needles for Endobronchial Ultrasonography in Suspected Lung Cancer. Respiration.
2018;96(3):275-282.
9. Nakajima T, Yasufuku K, Takahashi R, et al. Comparison of 21-gauge and 22-gauge aspiration
needle during endobronchial ultrasound-guided transbronchial needle aspiration. Respirology.
2011;16(1):90-94.
10. Oki M, Saka H, Kitagawa C, et al. Randomized Study of 21-gauge Versus 22-gauge
Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Needles for Sampling
Histology Specimens. J Bronchology Interv Pulmonol. 2011;18(4):306-310.
11. Saji J, Kurimoto N, Morita K, et al. Comparison of 21-gauge and 22-gauge Needles for
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration of Mediastinal and Hilar
Lymph Nodes. J Bronchology Interv Pulmonol. 2011;18(3):239-246.
12. Sakaguchi T, Inoue T, Miyazawa T, Mineshita M. Comparison of the 22-gauge and 25-gauge
needles for endobronchial ultrasound-guided transbronchial needle aspiration. Respir Investig.
2021;59(2):235-239.
13. Labarca G, Folch E, Jantz M, Mehta HJ, Majid A, Fernandez-Bussy S. Adequacy of Samples
Obtained by Endobronchial Ultrasound with Transbronchial Needle Aspiration for Molecular
Analysis in Patients with Non-Small Cell Lung Cancer. Systematic Review and Meta-Analysis.
Ann Am Thorac Soc. 2018;15(10):1205-1216.
14. Lim CE, Steinfort DP, Irving LB. Diagnostic performance of 19-gauge endobronchial ultrasound-
guided transbronchial needle aspiration (EBUS-TBNA) in suspected lymphoma: A prospective
cohort study. Clin Respir J. 2020;14(9):800-805.
15. Wolters C, Darwiche K, Franzen D, et al. A Prospective, Randomized Trial for the Comparison
of 19-G and 22-G Endobronchial Ultrasound-Guided Transbronchial Aspiration Needles;
Introducing a Novel End Point of Sample Weight Corrected for Blood Content. Clin Lung
Cancer. 2019;20(3):e265-e273.
16. Jones RC, Bhatt N, Medford ARL. The effect of 19-gauge endobronchial ultrasound-guided
transbronchial needle aspiration biopsies on characterisation of malignant and benign disease.
The Bristol experience. Monaldi Arch Chest Dis. 2018;88(2):915.
17. Pickering EM, Holden VK, Heath JE, Verceles AC, Kalchiem-Dekel O, Sachdeva A. Tissue
Acquisition During EBUS-TBNA: Comparison of Cell Blocks Obtained From a 19G Versus 21G
Needle. J Bronchology Interv Pulmonol. 2019;26(4):237-244.
18. Adler DG, Muthusamy VR, Ehrlich DS, et al. A multicenter evaluation of a new EUS core biopsy
needle: Experience in 200 patients. Endosc Ultrasound. 2019;8(2):99-104.
19. El H, II, Wu H, Reuss S, et al. Prospective Assessment of the Performance of a New Fine Needle
Biopsy Device for EUS-Guided Sampling of Solid Lesions. Clin Endosc. 2018;51(6):576-583.
20. Herth FJ, Eberhardt R, Vilmann P, Krasnik M, Ernst A. Real-time endobronchial ultrasound
guided transbronchial needle aspiration for sampling mediastinal lymph nodes. Thorax.
2006;61(9):795-798.
 AN2-V1/SGSOP 03/V1

Consent of Head of the PI’s Department

Date: 10th February 2022

I have reviewed the project “Prospective Randomized Controlled Study Comparing the
Diagnostic Yield and specimen adequacy of Flex 19G EBUS-TBNA Needles and 22G
EBUS-FNB device for the evaluation of mediastinal and hilar lymphadenopathy.”
submitted by Dr. Ajmal Khan Principal Investigator from my department. I endorse the project
and have ‘no objection’ for submission for consideration by Ethics committee.
I concur with the participants / investigators included in the study.

……………………… Dr. Alok Nath Pulmonary Medicine

Signature & date Name Department
 AN3-V1/SGSOP 03/V1

Research Committee/Department committee /Doctoral Committee/Scientific Committee

Approval

The project titled “Prospective Randomized Controlled Study Comparing the Diagnostic
Yield and specimen adequacy of Flex 19G EBUS-TBNA Needles and 22G EBUUS-FNB
device for the evaluation of mediastinal and hilar lymphadenopathy.” with all the
accompanying documents listed above was reviewed by the Research committee/department
committee /doctoral committee/scientific committee present on 10th February 2022 at SGPGI.
The committee has granted approval on the scientific content of the project. The proposal may
now be reviewed by the Institutional Ethics Committee for granting ethical approval.

…………………………Signature of *HOD/**Secretary (Research Committee) /***In charge

of doctoral committee or scientific committee

Name: Dr. Alok Nath

Date: 10th February 2022

*In case of student (MD/MS/DM/MCh) or independent project/extramural

**In case of intramural
***In case of PhD or any other project
****Not applicable to sponsor/CRO initiated drug/device trials

The PI should also attach a copy of minutes of “Research committee/department

committee /doctoral committee/scientific committee”.
 AN4-V1/SGSOP 03/V1

Undertaking by the Principal Investigator

1. Name of the project: “Prospective Randomized Controlled Study Comparing the

Diagnostic Yield and specimen adequacy of Flex 19G EBUS-TBNA Needles and 22G
EBUS-FNB device for the evaluation of mediastinal and hilar lymphadenopathy.”

2. Name, designation and department of the principal investigator:

Dr. Ajmal Khan
Additional Professor
Department of Pulmonary Medicine
SGPGIMS
Lucknow

3. Other members of the research team:

Dr. Alok Nath, Additional Professor, Department of Pulmonary Medicine, SGPGIMS,
Lucknow
Dr. Zia Hashim, Additional Professor, Department of Pulmonary Medicine, SGPGIMS,
Lucknow
Dr. Vinita Agarwal, Professor, Department of Pathology,SGPGIMS
4. Name and address of any other medical college, hospital or institution where parts of
the study will be done: None

5. Number of ongoing projects/clinical trials in which you are PI:

a. Number of clinical trials with active enrolments: _______
b. Number of clinical trials with follow up only: ___1____
c. Total number of ongoing projects (any) (Projects+a+b): ___1____

1. I confirm that I will initiate the study only after obtaining all regulatory clearances.
2. I will not implement any deviation from the approved protocol without prior consent of the
sponsor nature and it will be intimated to the IEC at the earliest.
3. I confirm that the Co-PI and other members of the study team have been informed about their
obligations and are qualified to meet them.
4. I will personally supervise the study and ensure that requirements of obtaining informed
consent and other ethical requirements under national regulatory and ICMR guidelines are
adhered to.
5. I will maintain accurate and complete record of all cases in accordance with GCP provisions
and make them available for audit/inspection by IEC, regulatory authorities, sponsors or their
authorized representatives.
6. I will inform the IEC and the sponsors of any unexpected or serious adverse event at the
earliest and definitely within seven days of its occurrence.
7. I will maintain confidentiality of the identity of all participating subjects and assure security
and confidentiality of study data.
8. I and my colleagues will comply with statutory obligations, requirements and guidelines
applicable to such clinical studies.
9. I will inform IEC if there is change in funding agency/status.
10. I will inform IEC of the date of starting the study within 2 weeks of initiation of the trial and
submit annual progress reports and final report to Member Secretary, IEC within 4 weeks of
the due date.

__________________________
Signature of PI

Name: Dr. Ajmal Khan Date__10th February 2022_____

 AN5-V1/SGSOP 03/V1

Conflict of Interest Declaration by PI

To,
The Member Secretary
Institutional Ethics Committee
SGPGI, Lucknow.

Project entitled: Prospective Randomized Controlled Study Comparing the Diagnostic

Yield and specimen adequacy of Flex 19G EBUS-TBNA Needles and 22G EBUS-FNB
device for the evaluation of mediastinal and hilar lymphadenopathy

Name of PI: Dr. Ajmal Khan

Conflict of Interest

[ √ ] I hereby declare that I have no conflict of interest in my project.

[ ] I have following conflict of interest:

______________________
Signature of PI

Name Dr. Ajmal Khan Date__10th February 2022___

 AN6-V1/SGSOP 03/V1
CV* of New or Investigator outside SGPGI or of the Student
Name: Dr. Ajmal Khan

Date of Birth (dd/mm/yy):13/08/1974 Sex: Male [√] Female [ ]

Study Site Affiliation (e.g. Principal Investigator, Co-Investigator, Coordinator):

Principal investigator
Professional Mailing Address: Study Sited Address:
(Include institution name) (Include institution name)
Department of Pulmonary Medicine Department of Pulmonary Medicine
SGPGIMS SGPGIMS
Lucknow Lucknow
Telephone (Office):0522 2495662 Mobile Number:8765974030
Telephone (Residence): 0522 2495661 E-Mail: [email protected]
Academic Qualifications (Most current qualification first):
Degree/Certificate Year Institution, Country
DM Pulmonary & Critical 2009 PGIMER Chandigarh
Care
MD Internal Medicine 2006 PGIMER Chandigarh

Current and Previous 3 Relevant Positions Including Academic Appointments

(Most current position first):
Month and Year Title Institution/Company, Country
July 2019 – till date Additional Professor SGPGIMS, Lucknow
July 2016 – 2019 Associate Professor SGPGIMS, Lucknow

2013-2016 Assistant Professor SGPGIMS, Lucknow

Brief Summary of Relevant Clinical Research Experience:

Signature: Date: 10th February 2022

*Signed and dated curriculum vitae of the investigators indicating qualifications and relevant experience for new or investigator
outside SGPGI or of the student (MD/MS/DM/MCh/PhD) who has submitted thesis/project
 AN7-V1/SGSOP 03/V1

PATIENT INFORMATION SHEET

1. Study Title:
“Prospective Randomized Controlled Study Comparing the Diagnostic Yield and specimen
adequacy of Flex 19G EBUS-TBNA Needles and 22G EBUS-FNB device for the evaluation
of mediastinal and hilar lymphadenopathy”
2. Invitation:
You are being invited to take part in a research study. Before you decide it is important for you
to understand why the study is being done and what it will involve. Please take time to read the
following information carefully and discuss it with friends, relatives and your treating
physician/family doctor if you wish. Ask us if there is anything that is not clear or if you would
like more information. Take time to decide whether or not you wish to take part.
3. Purpose of the study:
Establishing the etiology of mediastinal lymphadenopathy is often difficult as it may be caused
by infections like tuberculosis, malignancy or granulomatous diseases like sarcoidosis. Only way
to establish diagnosis in this disease is the aspiration of mediastinal lymph node. Thus effective
treatment can only be initiated if the cause of the disease is established. Transbronchial needle
aspiration is done either blindly or through ultrasound guidance. These methods are established
way of obtaining the transbronchial needle aspiration. EBUS guided needle aspiration has the
advantage of puncturing the needle under direct visualization thus preventing complications. No
new method of obtaining the aspiraion will be tried in you. You have been asked to take part in
the study because needle aspiration is already planned on you by your treating physician. This
study will only collect the data of the procedure regarding the diagnostic yield and complications
if any. .
4. Why have I been chosen?
You have been selected as study subject because you are suffering from mediastinal
lymphadenopathy the cause of which is not known so far. To confirm your disease you need to
undergo needle aspiration where the lymph node cells will be obtained and will be subjected to
cytological and histopathological examination to confirm your diagnosis. The decision to obtain
the needle aspiration on you is already been decided by your physician. Once the diagnosis is
known, your treatment can be started according to the histopathological diagnosis.
5. Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be
given this information sheet to keep and be asked to sign a consent form. If you decide to take
part you are still free to withdraw at any time before the procedure and without giving a reason.
This will not affect the standard of care you receive.
6. What do I have to do?
If you take part in the study then you have to give consent for endobronchial ultrasound with
needle aspiration using either 19 g or 22 g needle. You will not be charged any extra cost for the
test. You have to come fasting for at least 6 hours before the procedure.
7. What is the drug or procedure that is being tested?
Endobronchial ultrasound with needle aspiration is a new method to obtain the lymph node
aspirate which will rapidly confirm your disease. You will undergo endobronchial ultrasound
with needle aspiration which is routinely done in patients with mediastinal lymphadenopathy to
establish the etiological diagnosis. No new drug or procedure is being tested in this study. This
study only involves collection of data for the procedure you are undergoing.
8. What are the alternatives for diagnosis or treatment?
There is no alternative for lymph node aspiration that is why your treating physician has planned
a needle aspiration for you. Needle aspiration is the only way to establish the diagnosis.
Cytological and histopathological examination of your lymph node aspirate will guide your
physician for your effective treatment.
9.What are the possible disadvantages and risks of taking part?
All the tests that will be used during this study have already been used in this disease before and
information regarding their efficacy is known. Endobronchial ultrasound with needle aspiration
using either 19 g or 22 g needle is the standard test in the diagnosis of mediastinal
lymphadenopathy. The risks of bronchoscopy include pain or numbness in the throat and nose
for 2 hours and occasionally minor bleeding during procedure. Your may also feel choking due
to insertion of the scope but you will be monitored for your oxygenation.
10.What are the possible benefits of taking part?
We hope that your taking part in study will help us achieve a correct diagnosis of your problem.
However, this cannot be guaranteed. The information we get from this study may help us to treat
future patients with interstitial lung disease better.
11.Will my taking part in this study be kept confidential?
All information collected about you during the course of the research/trial will be kept strictly
confidential. Any information which leaves the hospital/clinic/laboratory will have your name
and address removed so that you cannot be recognized from it.
12.What will happen to the results of the research/trial study?
Study data will be published in any national/international scientific journal. We reassure you
once again that at no point of time your identity will be revealed.
13. Who is organizing and funding the research/trial?
This study is being conducted by the department of Pulmonary Medicine, SGPGIMS, Lucknow
and as it is a observational study where no extra procedure is involved, no funding is required

14.Who has reviewed the study?

Institute ethics committee

15.Contact for further information

Dr Ajmal Khan Dr Vineeta Agarwal
Additional Prof, Pulmonary Medicine Member Secretary, EC
SGPGIMS, Lucknow SGPGIMS, Lucknow
0522 2495662/8765974030 0522 2494918

_______________________
Signature of PI
Name: Dr Ajmal Khan Date: 10th February 2022
 AN8-V1/SGSOP 03/V2

Consent Form (English)

Study Title: “Prospective Randomized Controlled Study Comparing the Diagnostic Yield of
and specimen adequacy of Flex 19G EBUS-TBNA Needles and 22G EBUS-FNB device for
the evaluation of mediastinal and hilar lymphadenopathy”
Study Number____________________________________________________________
Subject’s Full Name (with father’s name)______________________________________
Date of Birth/Age_________________________________________________________
Address of subject ______________________________________________________________
_______________________________________________________________________
Qualification____________________
Occupation: Student/self-employed/service/housewife/other (please tick as appropriate)
Annual income of subjects__________________________
Name and address of nominee(s) and his relation to subject_____________________________
______________________________________________________________________________

1. I confirm that I have read and understood the information document dated ___________for
the above study and have had the opportunity to ask questions.
OR I have been explained the nature of the study by the Investigator and had the opportunity
to ask questions.
2. I understand that my participation in the study is voluntary and that I am free to withdraw at
any time, without giving any reason and without my medical care or legal rights being
affected.
3. I understand that the sponsor of the clinical trial/project, others working on the Sponsor’s
behalf, the Ethics Committee and the regulatory authorities will not need my permission to
look at my health records both in respect of the current study and any further research that
may be conducted in relation to it, even if I withdraw from the trial. However, I understand
that my Identity will not be revealed in any information released to third parties or published.
4. I agree not to restrict the use of any data or results that arise from this study provided such a
use is only for scientific purpose(s).
5. I permit the use of stored sample (tissue/blood) for future research. Yes [ ] No [ ]
6. I agree to take part in the above study.

Signature (or Thumb impression) of the Subject/Legally Acceptable Representative: __________

Signatory’s Name___________________________________Date________________________
Signature of the Investigator___________________________Date________________________
Study Investigator’s Name ____________________________

Signature of the Witness _____________________________Date________________________

Name of the Witness ______________________________

Received a signed copy of Participant Information Document and Consent Form.

Signature (or Thumb impression) of the Subject/Legally Acceptable Representative: __________

Date_______________________
 AN9-V1/SGSOP 03/V1

प्रतिभागी के लिए सूचना पत्र

अध्ययन शीर्षक
“ब्रोंकोस्कोपी अल्ट्रासाउंड निर्देशित १९ अथवा २२ नाप के सुई से छाती के
अंदर गाँठ का टुकड़ा निकालने का नियंत्रित परीक्षण”
निमंत्रण अनुछेद
आप को इस अध्ययन में भाग लेने के लिए आमंत्रित किया जा रहा है। भाग लेने से
पहले आप को यह समझना जरूरी है की यह अध्ययन क्यों किया जा रहा है और इस को
कैसे किया जाता है और इसमें आप की क्या सहभागिता है। कृपया आप अपना समय
निकल कर इस सूचना को पढ़ें तथा अपनी इच्छानुसार अपने मित्रों,परिजनों तथा
अपने चिकित्सक के साथ चर्चा करें। अगर आप को कोई जानकारी समझ में नहीं आती
है अथवा कोई अधिक जानकारी चाहिए तो हमें बताएं। इस अध्ययन के बारे में
पूरा समझ लेने के बाद आप अपनी स्वेच्छता से निर्णय लें की आप इस अध्ययन में
भाग लेना के लिए सहमत हैं या नहीं। अगर आप इस अध्ययन में भाग लेने के लिए
सहमत नहीं हैं तो इससे आप के इलाज पे कोई असर नहीं पड़ेगा।
अध्ययन का उद्देश्य क्या है?
आप के छाती के अंदर गाँठ है जिसका एक कारण कैंसर भी हो सकता है और निदान के
स्थापना के आभाव में इस रोग का इलाज ठीक प्रकार से होगा की नहीं सुनिश्चित
नहीं किया जा सकता। इस रोग के निदान स्थापित करने के लिए गाँठ का टुकड़ा
निकाल कर जांच करना ही एकमात्र प्रमाणित तरीका उपलब्ध है। गाँठ का टुकड़ा
निकलने के लिए दो तरीके उपलब्थ हैं,एक तरीका अंदाज से गाँठ की जगह सुई दाल
कर टुकड़ा निकलना है और दूसरा तरीका ब्रोंकोस्कोपी अल्ट्रासाउंड में देख
कर २२ अथवा २२ नाप के सुई से टुकड़ा निकलना है । दोनों तरीकों की उपयोगिता
पहले ही विदेशों में जांच द्वारा सिद्ध किया जा चूका है । ब्रोंकोस्कोपी
अल्ट्रासाउंड में देख कर टुकड़ा निकालने का विधि ज्यादा अच्छा होता है
क्यों कि इस विधि में गाँठ में पहुंचे कि नहीं हम देख पाते है और देख कर
बीमारी वाले कोने से टुकड़ा निकलते हैं। इस परीक्छण में हम ब्रोंकोस्कोपी
अल्ट्रासाउंड में देख कर २२ अथवा २२ नाप के सुई विधियों का परीक्छण करेंगे
जिसमें आप का टुकड़ा कौन से विधि से लिया जायेगा यह कंप्यूटर द्वारा
निर्धारित होगा ।अगर आप इस अधध्यन में भाग लेने के लिया सहमत नहीं होते
हैं तो भी गाँठ का टुकड़ा लेने का विधि यही रहेगा और दोनों विधि में से किसी
भी विधि का प्रयोग कर आप के गाँठ का टुकड़ा लिया जायेगा। अध्यन में सहमति कि
अवस्था में डॉक्टर द्वारा चुने गए विधि के बजाय कंप्यूटर द्वारा बताये गए
विधि से आप के छाती के अंदर के गाँठ का टुकड़ा लिया जायेगा परन्तु इस से आप
के इलाज में कोई फरक नहीं पड़ेगा।
मुझे इस अध्ययन के लिए क्यों चुना गया है?
आपके छाती के अंदर के गाँठ हो गया है जिसका निदान सामान्यतः होने वाली
जांचों से नहीं हो पाया है और इसका इलाज सफलतापूर्ण करने के लिए गाँठ के
कारण स्पष्ठ रूप से जानना अत्यंत आवश्यक है। स्पष्ट रूप से निदान के लिए
आपके गाँठ का टुकड़ा ब्रोंकोस्कोपी अल्ट्रासाउंड में देख कर २२ अथवा २२
नाप के सुई से लिया जायेगा। गाँठ के टुकड़े के जांच द्वारा आपका निदान
स्पष्ठ हो जायेगा और आपका निश्चित और प्रभावी इलाज सुनिश्चित किया
जायेगा।
क्या इसमें मुझे भाग लेना चाहिए?
यह आप पे निर्भर है की आप भाग लेना चाहते हैं की नहीं, यदि आप भाग लेने का
फैसला करते हैं तो आपको एक सूचना पत्र दिया जायेगा जिसमें इस अध्ययन की
बिस्तृत जानकारियां उपलब्ध हैं और एक सहमति फार्म पर हस्ताक्षर करने के
लिए कहा जायेगा। अध्ययन में भाग लेने का फैसला कर और सहमति पत्र पर
हस्ताक्षर करने के बाद भी किसी भी समय जांच से पहले किसी कारणवाश यदि आप
भाग नहीं लेना चाहते तो आप बिना कारण बताये वापस भाग न लेने के लिए
स्वतंत्र हैं। अध्ययन में भाग न लेने के कारण से आप के इलाज पर कोई असर
नहीं पड़ेगा।
मुझे क्या करना है?
यदि आप इस अध्ययन में भाग लेतें हैं तो आपको अपनी पहली उपस्थिति में
ब्रोंकोस्कोपी अल्ट्रासाउंड विधि से २२ अथवा २२ नाप के सुई से गाँठ का
टुकड़ा लेने के लिए सहमति देनी होगी। इस परीक्षण में संसथान द्वारा
सुनिश्चित जांच शुल्क के अतिरिक्त कोई भी शुल्क आप से नहीं लिया जायेगा।
इस जांच से पहले आप को काम से काम ६ घंटे पहले से उपवास करना होगा।
दवा या प्रक्रिया जिसका कि परीक्षण किया जा रहा है, क्या है?
इस प्रकार के रोगों के निदान के लिए नियमित रूप से गाँठ का टुकड़ा लेकर उस
टुकड़े का जांच किया जाता है। इस अध्ययन के प्रक्रिया में हम नियमित रूप से
किये जाने वाला ब्रोंकोस्कोपी अल्ट्रासाउंड विधि से २२ नाप के सुई का
तुलना २२ नाप के सुई से गाँठ का टुकड़ा लिए जाने की प्रभावकारिता का
मूल्याङ्कन करेंगे। ब्रोंकोस्कोपी अल्ट्रासाउंड विधि से टुकड़ा लेना एक
प्रकार से नई विधि है जिसका महत्व पहले भी बहुत सारे रोगियों में सिद्ध
किया जा चूका है।
इस प्रक्रिया में आपको फुसफुस विज्ञान के जांच इकाई में थोड़े समय के लिए
नींद की सुई द्वारा सुला कर ब्रोंकोस्कोपी अल्ट्रासाउंड विधि से जांच कर
आपकी गाँठ का टुकड़ा लिया जायेगा । जांच के समय जब आप निंद्रा में होंगे उस
समय आपकी महत्वपूर्ण अंगो की लगातार निगरानी रख्खी जाएगी ताकि जांच के
समय कोई जटिलता न आये । जटिलता आने की अवस्था में यह प्रक्रिया रोक दिया
जायेगा और उस जटिलता का पूरा इलाज किया जायेगा।
निदान या उपचार के लिए विकल्प क्या हैं?
आपके छाती के अंदर के गाँठ हो गया है जिसका एक कारण कैंसर भी हो सकता है और
इसका निदान स्थापित करने के लिए गाँठ के टुकड़े के जांच के आभाव में कोई
विकल्प नहीं है। गाँठ के टुकड़े का जांच इस प्रकार के रोग के निदान के लिए
आवश्यक है जोकि ब्रोंकोस्कोपी अल्ट्रासाउंड विधि से ही लिया जा सकता है।
इस अध्ययन में भाग लेने के संभावित जोखिम और नुकसान काया हैं?
हम आपको आश्वस्त करना चाहेंगे कि जो भी विधि इस प्रक्रिया में प्रयोग की
जा रही है उनका पहले भी अध्ययन हो चूका है और यह एक सुरक्षित विधि
सुनिश्चित की जा चुकी है। गांठ का टुकड़ा लिया जाना एक मानक परिक्षण है
जोकि इस प्रकार के बीमारी में नियमित रूप से किया जाता है। इसके जोखिम में
प्रक्रिया के बाद ४-६ घंटे तक नींद आना और मामूली रक्तस्राव होना है।
लेकिन इसके लिए आप को चिंता करने की जरुरत नहीं है, मामूली रक्तस्राव
थोड़े समय में अपने आप बंद हो जाता है और प्रर्किया के समय आप के महत्वपूर्ण
अंगो की लगातार निगरानी रही जाती है जिससे नुकसान होने की संभावना काम
होती है।
अध्ययन में भाग लेने के संभावित लाभ क्या हैं?
हमें आशा है कि इस प्रक्रिया से आपकी बीमारी का निदान स्पष्ट करने में मदद
मिलेगी लेकिन हम यह बात पूर्ण रूप से नहीं कह सकते कि गांठ के टुकड़े की
जांच से हर हालात में बीमारी का निदान स्थापित ही हो जायेगा। इसके इलावा
इस अध्ययन से प्राप्त जानकारी से हमें भविष्य में बहुत सारे लोगों के
बीमारी के निदान स्पष्ठ करने में मदद मिल सकती है। इस अध्ययन में भाग लेने
के कारण आपको इस प्रक्रिया की सुविधा अतिरिक्त लागत के बिना संसथान
द्वारा दी जा रही है।
क्या मेरे इस अध्ययन में भाग लेने को गोपनीय रखा जायेगा?
परिक्षण के समय आपके बारे में एकत्रित जानकारी पूर्ण रूप से गोपनीय राखी
जाएगी। अगर किसी जानकारी को प्रयोगसाला या संसथान के बाहर भेजा जायेगा तो
उससे पूर्व उस जानकारी से आप का नाम और ठिकाना हटा दिया जायेगा।

इस अध्ययन को कौन आयोजित कर रहा है और इस परिक्षण के लिए धन कहाँ से आएगा?

इस अध्ययन को संजय गाँधी स्नातकोत्तर चिकित्सा विज्ञान संस्थान के फुफुस
विज्ञान विभाग द्वारा आयोजित किया जा रहा है। यह प्रक्रिया विभाग में
संस्थान द्वारा निर्धारित मूल्यों पर नियमित रूप से किया जाता है और इस
अध्ययन के लिए अतिरिक्त लागत की आवश्यकता नहीं है।

इस अध्ययन का पूर्ण निरिक्षण किसने किया है?

इस अध्ययन का पूर्ण निरक्षण / पुर्नावलोकन हमारे संसथान की नैतिकता/आचार
समिति ने किया है तथा अध्ययन करने की सहमति दी है।

आधीक जानकारी के लिए निम्न लोगों से संपर्क करें

प्रमुख अन्वेषक का नाम अचार समिति के सदस्य सचिव का नाम
पता और दूरभाष नंबर पता और दूरभाष नंबर
डॉ अजमल खान डॉ विनीता अग्रवाल
एडिशनल प्रोफेसर प्रोफेसर
पल्मोनरी मेडिसिन विभाग विकृति विज्ञान विभाग
यस जी पी जी आई ऍम यस यस जी पी जी आई ऍम यस
लखनऊ लखनऊ
८७६५९७४०३० ८००४९०४५६१
प्रमुख अन्वेषक का हस्ताक्षर

प्रमुख अन्वेषक का नाम दिनांक

 सहमतिपत्र
अध्यन शीर्षक: “ब्रोंकोस्कोपी अल्ट्रासाउंड निर्देशित १९ अथवा २२ नाप
के सुई से छाती के अंदर गाँठ का टुकड़ा निकालने का नियंत्रित परीक्षण”
अध्यन संख्या:
प्रतिभागी का पूर्ण नाम (पिता के नाम के साथ):
जन्मतिथि / आयु:
पता :
वयवसाय: विद्यार्थी / स्वतः नियोजित / सरकारी सेवा / गृहणी / अन्य
(कृपया समुचित पर निशान लगाएं)
व्यक्ति की वार्षिक आय:
नामांकित व्यक्ति का नाम एवं पता / उनका वयक्ति से सम्बन्ध:
१. मैं पुष्टि करता हूं कि मैंने उपरोक्त अध्ययन के लिए सूचना दस्तावेज
को दिनांक ../../.... को पढ़ व समझ लिया है तथा मुझे जांचकर्ता द्वारा
अध्ययन की पूरी प्रकृति समझाई गई है तथा अध्धयन सम्बंधित प्रश्न पूछने का
समान अवसर प्रदान किया गया.
२. मैंने यह समझ लिया है कि अध्धयन में मेरी सहभागिता पूर्णतः स्वैछिक है
और मैं किसी भी समय किसी भी कारण के बिना मेरा इलाज अथवा कानूनी अधिकारों
को प्रभावित किये बिना अध्धयन में भाग न लेने के लिए स्वतंत्र हूँ ।
३. मैंने यह समझ लिया है कि अध्धयन के प्रायोजक, प्रायोजक कि तरफ से काम
करने वाले लोग, अचार समिति और नियामक अधिकारीयों को वर्त्तमान अध्यन के
सन्दर्भ में अथवा भविष्य के अध्यन के सन्दर्भ में मेरे स्वस्थ के अभिलेख
देखने के लिए मेरे अनुमति की आवश्यकता नहीं है चाहे मैंने इस अध्धयन से
अपनी सहमति वापस ले लिया हो परन्तु मैं यह सझता हूँ कि मेरी पहचान को किसी
भी तीसरी पछ्या अथवा प्रकाशित माध्यम को नहीं दिया जायेगा।
४. मैं इस बात से सहमत हूँ कि इस अध्धयन द्वारा उत्पन्न जानकारी या
परिणामों का उपयोग वैज्ञानिक उद्देश्य(ओं) के लिए मेरी तरफ से कोई
प्रतिबन्ध नहीं है ।
५. अगर इस अध्यन में संग्रहीत नमूना (खून या टिश्यू) भविष्य के अध्यन
में उपयोग हो तो मैं इसके लिए अपनी सहमति प्रदान करता हूँ । हाँ [ ]
नहीं [ ]
६. अध्यन से सम्बन्धी सारी जानकारी प्राप्त करने के बाद इस अध्यन में
सहभागिता के लिया मैं अपनी सहमति अपने स्वेछाता से देता हूँ ।
प्रतिभागी / कानूनी तौर पर स्वीकार्य प्रतिनिधि का हस्ताक्षर (या अंगूठे
का निशान)

हस्ताक्षर कर्ता का नाम दिनांक:

अन्वेषक के हस्ताक्षर दिनांक:
अध्यन अन्वेषक का नाम
गवाह के हस्तस्कार दिनांक:
गवाह का नाम

मैंने भागीदारी सूचना दस्तावेज और सहमति फॉर्म की एक हस्ताक्षरित प्रति

प्राप्त की

प्रतिभागी / कानूनी तौर पर स्वीकार्य प्रतिनिधि का हस्ताक्षर (या अंगूठे

का निशान)

DEPARTMENT OF PULMONARY MEDICINE

SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICIAL SCIENCES, LUCKNOW
CASE RECORD PROFORMA
Name Age/Gender Phone No.

CR No EBUS No

Clinical Diagnosis
 CT/EBUS Findings
LN CT Size CT Size EBUS Size EBUS Size Pass Core Jabbing Suction Visual
Station Short Long Short Axis Long Axis Nos. Appearance of
Axis Axis Aspirate
Bloody, Black,
Pus
2R
2L
4R
4L
7
10R
10L
11R
11L

LN Appearance on EBUS
LN Size Shape Margins Echogenicity Central Hilar Coagulation Central Intra-
Station (> 1cm,  (Oval, (Distinct, (Homogenous, Structures (Present, necrosis sign nodal vessels
1cm) Round) Indistinct) Heterogenous) absent) (present,
absent)
2R
2L
4R
4L
7
10R
10L
11R
11L
Ratio of the short to long axis of LN is more than 1.5 = Oval, Majority of the margins (>50%) clearly visualized with high echoic border =
Distinct margins, Echogenic difference between LN and the surrounding connective tissue structure = Heterogenous, Hypoechoic area within the LN
without blood flow = Coagulation necrosis sign

Clinical Parameters
Pre-Procedure 5 Min 10 min 15 Min 20 Min Post –Procedure 10 Min
HR
SBP
DBP
SPO2
LN Vascular Pattern on EBUS-Doppler
Grade 0 = No blood flow or small amounts of flow
Grade I = Few main vessels running toward the center of LN from the hilum
Grade II = Few punctifrom or rod-shaped flow signals, a few small vessels found as a long strip of a curve
Grade III = Rich flow more than foru vessels found with different diameters and a twist or helical flow signal
BA Inflow Sign = Blood flow arising from the bronchial artery towards the LN (AWAY FROM PROBE) visualized as blue signals with pulse
with EBUS color Doppler-mode

Previous Procedure (if any):

Additional Findings on CT:

Secretions – Minimal / Copious:

Cough – Minimal / Vigorous:

Sedation Used:

Complications:

Patient Comfort:
(Minimal / Uncomfortable)

Duration of the Procedure (Minutes):

Needle size used (22G/25G):

Aspiration:
Cytology Report

Histopathology Report

Culture Report

Gene Xpert Report

Additional Procedures:
TBLB
EBBx
BAL
Final Diagnosis:

Treatment:

Follow Up:

AN13-V1/SGSOP 03/V1
Checklist of Documents (6 copies and a CD of all documents listed below)
(Non Interventional trial require documents listed in Item no. 1 to 13)
Please give page no. to all documents (start from 1, 2, 3…………..40 and so on,)
*Please provide version no. and date of each document (for drug/device trial)
Protocol Title: “Prospective Randomised Controlled Study Comparing the Diagnostic
Yield of 22 and 25 Gauge Needles for Endobronchial Ultrasound Guided Transbronchial
Aspiration in Mediastinal & Hilar Lymphadenopathy”
Principal Investigator: Dr. Ajmal Khan

Type of document: Independent Study

Item Mandatory Documents (*with version and date) Yes No NA

No. Page
1. Document Receipt Form (to be submitted in duplicate, No.
AN14-V1/SGSOP 03/V1)
2. Project Submission Form (AN1-V1/SGSOP 03/V1) Y 1-7
3. Study Protocol (Review of literature, aim, methodology, Y 8-12
inclusion, exclusion criteria )
4. Case Report Form (form to capture data) Y 30-31
5. Consent of Head of the PI’s Department (AN2-V1/SGSOP Y 13
03/V1)
6. Research committee/department committee /doctoral Y 14
committee/scientific committee approval (AN3-V1/SGSOP
03/V1)
7. Undertaking by the PI (AN4-V1/SGSOP 03/V1) Y 15 - 16
8. Conflict of Interest Statement by PI (AN5-V1/SGSOP Y 17
03/V1)
9. CV of new or investigator outside SGPGI or of the student Y 18
(AN6-V1/SGSOP 03/V1)
10. Participant Information document (PID) & consent forms Y 19-29
CF) in English and Hindi (and if required in any other
language) (AN 7to 10 -V1/SGSOP 03/V1) * Include
guardian and parents
11. Child Information Document and assent form in English N
and Hindi (and if required in any other language) (AN11-
12-15V1/SGSOP 03/V1)
12. Ethics Committee clearance of other centers (in case of N
collaborative project)
13. Clinical Trials Registry- India (CTRI) is a pre-requisite for
clinical trials. In other case this must be done after approval
by IEC
14. Investigator Brochure
15. Advertisement/Information brochure
16. Insurance policy and certificate
17. DCGI approval letter/DCGI submission letter
18. NOC from DCGI /ICMR/DBT
19. Director General of Foreign Trade (DGFT)
approval in case study samples are to be sent
 abroad for analysis
20. Genetic Engineering Advisory Committee
(GEAC) approval in case study involves use of
gene therapy/recombinant DNA
21. Bhabha Atomic Research Centre (BARC)
approval in case study involves use of
radioisotopes/ionizing radiations
22. Stem cell (NAC-SCRT registration and approval)
23. DCGI marketing/manufacturing license for
herbal formulations/nutraceutics
24. Clinical Trial Agreement (CTA)/Memorandum of
Understanding (MOU)
25. Material Transfer Agreement (MTA)- Health Ministry
Screening Committee (HMSC) approval in case the study
involves collaboration with any foreign
laboratory/clinic/institution
26. IEC processing fee (applicable for sponsored trials)
27. Any other documents
 AN14-V1/SGSOP 03/V1
IEC Document Receipt Form (to be submitted in duplicate)

Type of o New 
Submission: o Revised
Protocol Title: “Prospective Randomised Controlled Study Comparing the Diagnostic
Yield of 22 and 25 Gauge Needles for Endobronchial Ultrasound Guided Transbronchial
Aspiration in Mediastinal & Hilar Lymphadenopathy”
Principal Investigator: Dr. Ajmal Khan

Type of document: Independent Study

Checklist to assess the projects before they are submitted to IEC review
Item No. Mandatory Documents (*with version and date) Yes No NA
1. Document Receipt Form (to be submitted in Page No.
duplicate, AN14-V1/SGSOP 03/V1)
2. Project Submission Form (AN1-V1/SGSOP 03/V1) Y 1-7
3. Study Protocol (Review of literature, aim, Y 8-12
methodology, inclusion, exclusion criteria )
4. Case Report Form (form to capture data) Y 30-31
5. Consent of Head of the PI’s Department Y 13
(AN2-V1/SGSOP 03/V1)
6. Research committee/department committee/doctoral Y 14
committee/scientific committee approval (AN3-
V1/SGSOP 03/V1)
7. Undertaking by the PI (AN4-V1/SGSOP 03/V1) Y 15 - 16
8. Conflict of Interest Statement by PI Y 17
(AN5-V1/SGSOP 03/V1)
9. CV of new or investigator outside SGPGI or of the Y 18
student (AN6-V1/SGSOP 03/V1)
10. Participant Information document (PID) & consent Y 19-29
forms CF) in English and Hindi (and if required in
any other language) (AN 7to 10 -V1/SGSOP
03/V1) * Include guardian and parents
11. Child Information Document and assent form in N
English and Hindi (and if required in any other
language) (AN11-12-15V1/SGSOP 03/V1)
12. Ethics Committee clearance of other centers (in case N
of collaborative project)
13. Clinical Trials Registry- India (CTRI) is a pre-
requisite for clinical trials. In other case this must be
done after approval by IEC
14. Investigator Brochure
15. Advertisement/Information brochure
16. Insurance policy and certificate
17. DCGI approval letter / DCGI submission letter
18. NOC from DCGI /ICMR/DBT
19. Director General of Foreign Trade (DGFT)
approval in case study samples are to be sent
abroad for analysis
20. Genetic Engineering Advisory Committee
(GEAC) approval in case study involves use of
gene therapy/recombinant DNA
21. Bhabha Atomic Research Centre (BARC)
approval in case study involves use of
radioisotopes/ ionizing radiations
22. Stem cell (NAC-SCRT registration and approval)
23. DCGI marketing/manufacturing license for
herbal formulations/ nutraceutics
24. Clinical Trial Agreement (CTA)/Memorandum of
Understanding (MOU)
25. Material Transfer Agreement (MTA)- Health
Ministry Screening Committee (HMSC) approval in
case the study involves collaboration with any
foreign laboratory/clinic/institution
26. IEC processing fee (applicable for sponsored trials)
27. Any other documents
*Please provide version no. and date of each document (for drug/device trial)

Documents submitted:
( ) Complete

( ) Incomplete; will submit on…………...

Comments:

Receiver Name, Sign & Date:_______________________________________________

(Bioethics cell)

Project submitted by Name & sign:__________________________________________

(Project or study team member)