Trial Title:
Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions
NCT ID:
NCT05804786
Condition:
Lung Cancer
Conditions: Keywords:
Electromagnetic Navigation Bronchoscopy
Guided Bronchoscopy
Diagnosis
Radial Endobronchial Ultrasound
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Guided bronchoscopy
Description:
It is performed when a pulmonary lesion with a possibility of malignancy is found on
chest CT and histological diagnosis and differentiation are required.
Arm group label:
single group
Other name:
Device: Spin Thoracic Navigation System
Other name:
Device: Radial EBUS probe
Summary:
The primary objective is To evaluate the usefulness and safety of advanced guided
bronchoscopy for histological diagnosis of peripheral pulmonary lesions.
The Secondary objective is to establish a strategy that can most effectively use
endoscopes for early diagnosis of lung cancer in a real-world care environment by
identifying patient/clinical/image/procedure-related characteristics that can optimize
the practicality of emerging technologies.
Detailed description:
- Patients with peripheral pulmonary lesions who need histological diagnosis due to
suspected lung cancer and whose lesions are judged capable of histological
examination through guided bronchoscopy will be prospectively recruited.
- This study is a pure non-interventional pragmatic design. In addition to biopsy for
lung lesions using bronchoscopy, lung cancer staging and tests necessary for
metastases and treatment for diagnosed lung cancer are performed according to
existing guidelines and the judgment of medical staff.
- We will analyze the clinical characteristics of guided bronchoscopy procedures used
in clinical practice and the main results during the follow-up period of up to one
year (diagnostic yield, sensitivity, safety, practicality, and various factors
affecting usefulness).
Criteria for eligibility:
Study pop:
Patients with peripheral pulmonary lesions that require histological differentiation
because of the possibility of malignancy and are scheduled for biopsy attempted through
guided bronchoscopy
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Patients who agreed in writing to participate in this study
2. Adult men and women over 19 years of age
3. Patients who visited the hospital with lung lesions suspected of lung cancer and
require a diagnostic biopsy
4. Patients capable of biopsy through guided bronchoscopy
Exclusion Criteria:
1) Patients who are unable to express their opinions and cannot cooperate due to a lack
of cognitive function
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dongsan Hospital Keimyung University School of Medicine
Address:
City:
Daegu
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sun Hyo Park
Facility:
Name:
Hallym University Dongtan Sacred Heart Hospital
Address:
City:
Gyeonggi-do
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
So Jeong Kim
Facility:
Name:
Chunnam National University Hwasun Hospital
Address:
City:
Hwasun
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyung Joo Oh
Facility:
Name:
Inje University Ilsan Paik Hospital
Address:
City:
Ilsan
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyung Gu Kang
Facility:
Name:
Gyeongsang National University Hospital
Address:
City:
Jinju
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jong Whan Jeong
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yeon Wook Kim, MD, PhD
Phone:
+82-31-787-8134
Email:
kimyw@snu.ac.kr
Facility:
Name:
Asan Medical Center, University of Ulsan College of Medicine
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Wonjun Ji
Facility:
Name:
Gangnam Severence Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Chi Young Kim
Facility:
Name:
Hanyang University Hostpital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Dong Won Park
Facility:
Name:
The Catholic University of Korea, Seoul, Korea
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyeong Jun Cho
Facility:
Name:
Pusan National University Yangsan Hospital
Address:
City:
Yangsan
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Seong Hoon Yoon
Start date:
April 1, 2023
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Seoul National University Bundang Hospital
Agency class:
Other
Source:
Seoul National University Bundang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05804786
