The Role of Narrow Band Imaging (NBI) Bronchoscopy in Detecting Bronchial Squamous Dysplasia in Lung Cancer
Conditions: Pulmonary Cancer, Lung Cancer
Sponsor: Indonesia University

 
 
 
The Role of Narrow Band Imaging (NBI) 
Bronchoscopy in Detecting Bronchial Squamous 
Dysplasia in Lung Cancer 
 
 
 
 
 
 
 
 
 
 
Mia Elhidsi, MD 
 
Department of Pulmonology and Respiratory Medicine, Persahabatan 
Hospital, Faculty of Medicine Universitas Indonesia 
ID: ND-552/UN2.RST/PPM.00.00/2023 
 
October 26th, 2023 
 
 

 
1. Title 
The Role of Narrow Band Imaging (NBI) Bronchoscopy in Detecting Bronchial Squamous 
Dysplasia in Lung Cancer 
 
2. Ethical clearance 
The date of approval from Health Research Ethics Committee Faculty of Medicine 
Universitas Indonesia, Dr. Cipto Mangunkusumo General Hospital is 23rd March 2023 
(KET-361/UN2.F1/ETIK/PPM.00.02/2023 
 
3. Study Protocol 
 
- 
Problem Statement 
1. What are the NBI imaging criteria for detecting bronchial squamous dysplasia in 
lung tumor patients? 
2. How does the diagnostic profile of NBI bronchoscopy compare with standard 
bronchoscopy (white light bronchoscopy, WLB) in detecting bronchial squamous 
dysplasia in lung tumor patients?  
3. Can the addition of NBI to standard bronchoscopy procedures improve diagnostic 
accuracy in detecting bronchial squamous dysplasia in lung tumor patients?  
 
- 
Research Objectives 
This research aims to determine the diagnostic profile (area under the curve, AUC; 
sensitivity, specificity, positive predictive value, and negative predictive value) of 
NBI bronchoscopy in detecting bronchial squamous dysplasia in lung tumor 
patients. 
 
4. Method 
- 
Study Design 
This is an observational diagnostic study. The research was conducted at the 
bronchoscopy suite of Persahabatan Hospital, where bronchoscopy procedures, 
bronchial biopsy collection, and specimen handling took place. The histopathological 
examinations were carried out in the Department of Anatomical Pathology, Faculty of 
Medicine, Universitas Indonesia, The patient recruitment time ranges from March to 
December 2023. 
- 
Population 
The target population consists of all lung tumor patients. The accessible population 
consisted of lung tumor patients who underwent bronchoscopy procedures at 
Persahabatan Hospital from March to December 2023. 
- 
Study participants 

The study participants comprised individuals from the accessible population who met 
the research participants acceptance criteria and provided informed consent. The 
consecutive sampling method was employed. 
- 
Study participants calculation 
The study participants size was calculated using the diagnostic research sample size 
formula. The minimum sample size required was 110 participants 
- 
Inclusion criteria 
1. Patient aged > 18 years undergoing bronchoscopy for diagnostic evaluation of lung 
tumors 
2. Recent radiological examinations, including both chest X-ray and chest CT scans, 
within the last month, revealed a central lesion of lung cancer 
- 
Exclusion criteria 
1. Refusal to provide informed consent 
2. Contraindications to bronchoscopy 
- 
Participants selection 
Screening was conducted on all lung tumor patients scheduled for bronchoscopy 
procedures, and the participants selection was carried out in accordance with the 
inclusion and exclusion criteria 
- 
Sampling Technique 
The preparation and execution of bronchoscopy and bronchial biopsy were performed 
in accordance with the standard operating procedures (SOP) at Persahabatan Hospital. 
The bronchoscopy and bronchial biopsy procedures were conducted by a single 
operator, the principal investigator. The bronchoscopy procedure uses general 
anesthesia. The flexible fiberoptic bronchoscopy was performed using an Olympus 
EVIS EXERA III with a Xenon light source, model CLV-190, and BF-1TQ170 series 
scope. The Boston Scientific Radial JawTM 4 disposable lung biopsy forceps were 
employed. Bronchoscopy was initially performed under the white light, followed by 
the activation of the NBI feature for airway inspection. Biopsies were obtained from 
areas identified through NBI bronchoscopy findings. Furthermore, the criteria for 
bronchoscopy images suspected for dysplasia included the presence of dotter vessels, 
capillary loops, tortuous vessels, and abrupt ending vessels. No biopsies were 
conducted on infiltrative neoplasms or tumors. The biopsied tissue was then preserved 
in a separate 10% formalin solution. Tissue processing involved paraffin embedding 
and Hematoxylin-Eosin staining. Tissue processing was performed using a Tissue 
Processor machine. Following tissue processing, paraffin blocks were created and 
sectioned. Hematoxylin-Eosin staining was then performed. Diagnosis of squamous 
bronchial dysplasia (pre-cancer lesion) was made by a specialist in Anatomical 
Pathology. 
 
5. Statistical Analysis Plan (SAP) 

The research data were recorded on research forms and subsequently entered into SPSS 
26 software. the bivariate analysis was conducted between each vascular pattern based on 
NBI bronchoscopy and the histopathological result. The descriptive data will be presented 
by the text and tables consist of the basic characteristics of the study participants and 
research variables. The multivariate analysis was performed on all vascular patterns based 
on NBI bronchoscopy and histopathological results. Furthermore, a pre-cancer prediction 
score was generated. An analysis of the AUC (area under the curve) of the squamous 
dysplasia prediction model form NBI bronchoscopy findings was conducted with a 
significance level set at p < 0.0.5

 
6. Informed Consent Form (ICS) 
 
  MR Number 
: …………………………… 
  
  Name  
: ……………………………… 
RSUP PERSAHABATAN   Sex 
: ……………………………… 
Jl. Persahabatan Raya No. 1   Date of Birth 
:……………………………………
. 
East Jakarta, Phone. 021-
4891708 / Fax : 021-4711222 
 
 
MEDICAL PROCEDURE CONSENT FORM 
 INFORMED CONCENT 
Principal Investogator 
  
dr. Mia Elhidsi, SpP(K) 
Informant 
  
Recipient of Information 
  
  
NO 
Type of 
Information 
Information 
Checklist (V) 
1 
Aims 
To understand the relationship 
between narrow-band imaging 
(NBI) bronchoscopy and 
bronchial dysplasia abnormality 
  
2 
Research benefit 
To determine whether the 
patient has respiratory damage, 
to ascertain whether the patent is 
suffering from lung cancer; to 
establish whether the patient has 
lung cancer metastasis 
  
3 
Procedures 
  
  
  
a. Protocol 
1. Participants over 18 years old 
with a diagnosis of lung tumor 
without metastasis to the 
adjacent lung tissue who 
undergo bronchoscopy 
procedure at Persahabatan 
Hospital between March to 
December 2023 will be invited 
to participate in the research 
  
  
  
2. Research participants will 
sign an informed consent form 
  

  
  
3. Some necessary data will be 
collected 
  
  
  
4. Tissue samples will be taken 
from the tumor and the other 
lung using a bronchocope 
  
  
  
5. The disposable equipment 
will be used for the tissue 
collection to avoid 
contamination 
  
  
  
6. Bronchoscopy was initially 
performed under the white 
light, followed by the 
activation of the NBI feature 
for airway inspection.  
  
  
  
7. Biopsies were obtained 
from areas identified through 
NBI bronchoscopy findings. 
No biopsies were conducted 
on infiltrative neoplasms or 
tumors. 
  
  
  
8. The bronchoscopy procedure 
and tissue collection will be 
documented with video 
recording 
  
  
b. Risk 
1. Bronchoscopy procedures in 
patients may cause discomfort 
  
  
  
2. There is a risk of respiratory 
tract infection due to the 
bronchoscopy procedure. 
However, this can be prevented 
by washing hands before and 
after the procedure, and using 
disposable biopsy tools 
  
  
  
3. Some other risks, such as 
bleeding, may occur during the 
bronchoscopy procedure. 
Nevertheless, this can be 
prevented by conducting the 
procedure carefully based on 
standard operating procedures 
(SOP) 
  

  
c. 
Complications/sid
e effect 
Complications that occur from 
bronchoscopy procedures 
include bleeding or anaesthesia-
related issue during the 
procedure. However, these can 
be avoided by conducting the 
procedure carefully based on the 
SOP 
  
  
d. Actions to be 
taken in case of 
complications/side 
effect  
In the event of 
complications/side effects, the 
bronchoscopy procedure will be 
stopped, and appropriate 
measures will be taken to 
address the specific 
complication or side effect that 
arises.  
  
  
e. Compensation 
in case of 
complications 
There will be no additional 
compensation provided 
  
  
1). Confidentiality 
The identity of each research 
participants will be kept 
confidential. 
  
  
2). Participants 
right to withdraw 
Research participants have the 
right to withdraw from the study 
at any time. 
  
  
3). Voluntary 
participation 
Participation in the study is 
entirely voluntary, and potential 
research participants will be 
given the opportunity to read the 
informed consent document and 
have time to consider their 
participation before enrolling in 
the study. 
  
I declare that I have explained the above matters correctly and 
clearly, and have provided the opportunity for questions and/or 
discussion. 
Signature 
I acknowledge that I have received information from the 
researcher as described above, and I have placed my 
signature/initials in the right-hand column, indicating my 
understanding 
Signature 
*) If the research participants is not competent or unwilling to receive information, then the 
recipient of the information will be the legal guardian or closest family member. 
 

Information for Potential Research Participants 
 
My name is dr. Mia Elhidsi, SpP(K), the principal investigator at Persahabatan Hospital of a 
research study titled “The Role of Narrow-Band Imaging (NBI) Bronchoscopy in Detecting 
Bronchial Squamous Dysplasia in Lung Cancer. This document provides an explanation of the 
research study and can be read to understand what will be done and what is required if you choose 
to participate. 
 
1. Research Objectives 
This research aims to determine the accuracy of NBI bronchoscopy in detecting pre-cancerous 
lesion in patients with lung tumor. What is NBI bronchoscopy? It is a bronchoscopy feature 
that provides images with higher contrast compared to standard bronchoscopy images. This 
feature enabling more accurate detection of airway abnormalities. Additionally, this study 
aims to investigate the correlation between NBI bronchoscopy findings and epithelian 
bronchial dysplasia in lung tumors. 
 
2. Participation in the Research 
You are invited to participate in this research. Participation is voluntary. The research will run 
from approximately March to December 2023. Your involvement will include interviews, 
physical examinations, bronchoscopy procedures, and airway tissue biopsies. If you agree to 
participate and meet the research criteria, you will undergo a bronchoscopy procedure as 
usual, followed by bronchoscopy with narrow-spectrum light features and biopsy if 
abnormalities are detected. Tissue biopsies will be evaluated by the Department of Pathology 
at Persahabatan Hospital. 
 
3. Selection Criteria 
Based on the initial criteria, you are considered a suitable candidate for this research if you 
are meet some criteria, including: 
- 
An adult, aged over 18 years at the time of consent. 
- 
Undergoing bronchoscopy due to a lung tumor for diagnostic purposes. 
 
You cannot participate in the research if: 
- 
You do not consent to the research's informed consent form. 
- 
You have contraindications related to bronchoscopy procedures, such as blood pressure 
and heart rhythm-related conditions, recent heart attacks, uncontrolled heart rhythm 
disorders, a history of chest pain, and blood oxygen gas level disturbances. 
Additionally, you cannot undergo bronchoscopy if you have contraindications related 
to the pre-procedure anaesthesia, such as a history of severe bleeding disorders. 
- 
You are severely ill patients (bedridden category) or require assistance with daily 
activities. 

 
Based on the initial criteria, we will conduct a comprehensive review to determine your 
eligibility for our research. 
 
4. Research Procedures 
a. Information about Intervention Procedures 
Before participating in the research, you will undergo several examinations to ensure your 
suitability for the research. 
- 
Prior to research participation, you will undergo initial examinations to assess your 
eligibility. 
- 
You will be interviewed by a doctor to inquire about your name, age, medical history, 
pain complaints, family history of cancer, and smoking history. 
- 
The doctor will conduct a physical examination and enter data from additional 
supportive examinations, such as laboratory and radiological tests. 
- 
If you meet the criteria for research participation and agree to sign the consent form, 
the doctor will prepare you for bronchoscopy and airway tissue biopsy procedures 
according to the standard operating procedures at Persahabatan Hospital 
- 
The bronchoscopy and biopsy procedures will be performed by the researcher. Before 
the procedure, you will be anesthetized according to Persahabatan Hospital’s standard 
operating procedures. 
- 
The researcher will use a disposable biopsy forceps for tissue sampling. 
- 
Biopsies were obtained from areas identified through NBI bronchoscopy findings.  
- 
The doctor will assess and collect tissue (biopsy) from three airway areas: Area 1: 
Trachea and carina, Area 2: Main right and left bronchi and their branches. 
- 
Biopsies were obtained from areas identified through NBI bronchoscopy findings. No 
biopsies were conducted on infiltrative neoplasms or tumors. 
- 
Tissue samples from each area will be placed in separate 10% formalin solution. 
- 
Subsequently, the tissues will be processed using paraffin blocks and Haematoxylin-
Eosin staining by technicians from the Department of Pathology at Persahabatan 
Hospital 
- 
The examination results will be recorded on research forms. 
 
b. Currently Available Alternative Procedures 
If you choose not to participate in this research, the alternative procedure available at this 
time is white light bronchoscopy, which provides images without contrast. 
 
5. Risk, Side Effect, and Management 
NBI bronchoscopy itself does not have side effects or complications. Additionally, the side 
effects can occur due to the bronchoscopy intervention procedure. Possible complications and 
side effects are include pain, discomfort during the procedure, increased risk of respiratory 

infections, bleeding in the airway, and complications due to pre-procedure anaesthesia. 
However, these risks and side effects can be minimized by conducting the procedure carefully 
and in accordance with standard operating procedures (SOP). The bronchoscopy procedures 
conducted at Persahabatan  Hospital have been safe. 
 
In the case of complications/side effects, the bronchoscopy procedure will be stopped, and 
management will be carried out according to the specific complication/side effect by the 
bronchoscopy and anaesthesia team. 
 
If needed, you are free to contact us and discuss any concerns. You will be informed before 
proceeding with the next steps of the research. 
 
6. Benefits 
The use of NBI bronchoscopy imaging to assess airway abnormalities in lung tumor patients 
offers the benefit of improving the accuracy of early lung cancer detection. It also contributes 
to the foundation of knowledge for the development of further lung cancer management. 
 
7. Compensation 
By participating in this research, you will receive additional examinations that are not 
routinely performed on other patients, such as NBI bronchoscopy. 
 
8. Financing 
You will not incur additional charges for NBI bronchoscopy. The costs of bronchoscopy and 
other diagnostic procedures will be covered based on your healthcare insurance. 
 
9. Confidentiality 
If you choose to participate in this research, all your data will be kept confidential. Research 
presentations at scientific meetings/conferences and publications in scientific journals will not 
include your name. 
 
10. Research Participants Obligations 
As a research participants, you are obligated to follow the research rules and guidelines as 
outlined above. If anything is unclear, you can ask the researcher for further clarification. 
 
11. Right to Refuse and Withdraw 
You are not obligated to participate in this research, and if you choose not to, your decision 
will not affect the treatment you receive at our hospital. You are also free to withdraw from 
the research at any time. It is your personal choice, and your rights will be respected. 
 

We will provide you with an opportunity at the end of this explanation to consider your 
decision. 
 
12. Additional Information 
You are encouraged to ask any questions about the research that are not yet clear. If you 
experience any side effects or require further explanations, you can contact: 
 
Dr. Mia Elhidsi, Sp.P(K) 
Rawamangun, East Jakarta 13220 
Phone: 081386633191 
Email: miapulmo.ui@gmail.com 
 
This proposal has been reviewed and approved by the Research Ethics Committee of the 
Faculty of Medicine, Universitas Indonesia, and Persahabatan Hospital; a committee 
responsible for ensuring participant protection from harm.