Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions
- Conditions
- Lung Cancer
- Interventions
- Device: Guided bronchoscopy
- Registration Number
- NCT05804786
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1240
- Patients who agreed in writing to participate in this study
- Adult men and women over 19 years of age
- Patients who visited the hospital with lung lesions suspected of lung cancer and require a diagnostic biopsy
- Patients capable of biopsy through guided bronchoscopy
- Patients who are unable to express their opinions and cannot cooperate due to a lack of cognitive function
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description single group Guided bronchoscopy Patients with peripheral pulmonary lesions which require histological differentiation because of the possibility of malignancy, and a biopsy can be attempted through guided bronchoscopy
- Primary Outcome Measures
Name Time Method Diagnostic yield at index Upon reports of pathologic results (up to 2 weeks after bronchoscopy) The proportion of pathologic results that leads to a specific malignant or benign
- Secondary Outcome Measures
Name Time Method Diagnostic accuracy at 12 months Confirmed by follow-up results at 1 year True positive + True negative (confirmed benign with follow-up of at least 1yr without progression) / Total procedures
Pathologic results of a malignant or benign specific diagnosis based on the samples collected via index ENB procedure are categorized as true positives or true negatives.
For pathologic results of a benign non-specific diagnosis and non-diagnostic results, follow-up data would be used to determine whether the 12-month status corroborates the benign results. Based on definition scenarios, these results will be determined as true negatives or false negatives. Diagnostic yields based on different scenarios will be reported.Sensitivity for malignancy Confirmed by follow-up results at 1 year True positive/Confirmed malignancy cases
Complication Confirmed by follow-up results at 1 year Evaluate complications due to guided bronchoscopic biopsy
Trial Locations
- Locations (11)
Gangnam Severence Hospital
🇰🇷Seoul, Korea, Republic of
Dongsan Hospital Keimyung University School of Medicine
🇰🇷Daegu, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Chunnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine
🇰🇷Seoul, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of
The Catholic University of Korea, Seoul, Korea
🇰🇷Seoul, Korea, Republic of
Hanyang University Hostpital
🇰🇷Seoul, Korea, Republic of