Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102369
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-06
First Post:
2023-10-22
Brief Title:
The Role of Narrow Band Imaging NBI Bronchoscopy in Detecting Bronchial Squamous Dysplasia in Lung Cancer
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
The Role of Narrow Band Imaging NBI Bronchoscopy in Detecting Bronchial Squamous Dysplasia in Lung Cancer
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Investigators conducted an observational diagnostic study The primary objective of the study is to develop a scoring system for detecting pre-lung cancer abnormalities using narrow-band imaging NBI bronchoscopy From the collected data investigators will perform a multivariate analysis based on the odds ratio OR using IBM SPSS software The result of the data analysis will be transformed into a scoring system aimed to facilitate the early diagnosis of lung cancer specifically at the pre-cancer stage This scoring system will also help clinicians detect pre-cancerous abnormalities early and improve patient recovery prospects
Several research questions to be addressed are as follows
1 What are the NBI image criteria for detecting pre-cancerous lesions in lung tumor patients
2 What is the diagnostic profile of NBI bronchoscopy in detecting pre-cancerous lesions in lung tumor patients
3 Can adding the NBI bronchoscopy procedure to the standard bronchoscopy procedure enhance the diagnostic accuracy in detecting pre-cancerous lesions in lung tumor patients
The study population consists of lung tumor patients who have undergone bronchoscopy procedures and meet the protocol acceptance criteria Bronchial biopsies will be collected from these patients followed by histopathological examinations
Several research questions to be addressed are as follows
1 What are the NBI image criteria for detecting pre-cancerous lesions in lung tumor patients
2 What is the diagnostic profile of NBI bronchoscopy in detecting pre-cancerous lesions in lung tumor patients
3 Can adding the NBI bronchoscopy procedure to the standard bronchoscopy procedure enhance the diagnostic accuracy in detecting pre-cancerous lesions in lung tumor patients
The study population consists of lung tumor patients who have undergone bronchoscopy procedures and meet the protocol acceptance criteria Bronchial biopsies will be collected from these patients followed by histopathological examinations
Detailed Description:
1 Study Design This is an observational diagnostic study The research was conducted at the Central Surgical Installation CSI 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 Cipto Mangunkusumo National General Hospital The patient recruitment time ranges from March to December 2023
2 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
3 The study participants The study participants comprised individuals from the accessible population who met the research subject acceptance criteria and provided informed consent The consecutive sampling method was employed
4 Study participants size calculation The study participants size was calculated using the diagnostic research sample size formula The minimum study participants size required was 110 subjects
5 Inclusion criteria
Patient aged 18 years undergoing bronchoscopy for diagnostic evaluation of lung tumors
Recent radiological examinations including both chest X-ray and chest CT scans within the last month revealed a central lesion of lung cancer
6 Exclusion criteria
Refusal to provide informed consent
Contraindications to bronchoscopy
7 Study participants selection Screening was conducted on all lung tumor patients scheduled for bronchoscopy procedures and the study participants selection was carried out in accordance with the inclusion and exclusion criteria
8 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 conducted under the white light followed by narrow-spectrum light The NBI assessment was performed in two areas consisting of area 1 trachea and carina and area 2 right main bronchus right upper lobe orifice truncus intermedius right lower lobe orifice left main bronchus left upper lobe orifice and left lower lobe orifice Biopsies were taken from both areas based on the NBI bronchoscopy findings Tissue from each area was placed 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
9 Data analysis 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 005
2 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
3 The study participants The study participants comprised individuals from the accessible population who met the research subject acceptance criteria and provided informed consent The consecutive sampling method was employed
4 Study participants size calculation The study participants size was calculated using the diagnostic research sample size formula The minimum study participants size required was 110 subjects
5 Inclusion criteria
Patient aged 18 years undergoing bronchoscopy for diagnostic evaluation of lung tumors
Recent radiological examinations including both chest X-ray and chest CT scans within the last month revealed a central lesion of lung cancer
6 Exclusion criteria
Refusal to provide informed consent
Contraindications to bronchoscopy
7 Study participants selection Screening was conducted on all lung tumor patients scheduled for bronchoscopy procedures and the study participants selection was carried out in accordance with the inclusion and exclusion criteria
8 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 conducted under the white light followed by narrow-spectrum light The NBI assessment was performed in two areas consisting of area 1 trachea and carina and area 2 right main bronchus right upper lobe orifice truncus intermedius right lower lobe orifice left main bronchus left upper lobe orifice and left lower lobe orifice Biopsies were taken from both areas based on the NBI bronchoscopy findings Tissue from each area was placed 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
9 Data analysis 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None