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.
* 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).
Study Type
OBSERVATIONAL
Enrollment
1,240
It is performed when a pulmonary lesion with a possibility of malignancy is found on chest CT and histological diagnosis and differentiation are required.
Dongsan Hospital Keimyung University School of Medicine
Daegu, South Korea
RECRUITINGHallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, South Korea
RECRUITINGDiagnostic yield at index
The proportion of pathologic results that leads to a specific malignant or benign
Time frame: Upon reports of pathologic results (up to 2 weeks after bronchoscopy)
Diagnostic accuracy at 12 months
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.
Time frame: Confirmed by follow-up results at 1 year
Sensitivity for malignancy
True positive/Confirmed malignancy cases
Time frame: Confirmed by follow-up results at 1 year
Complication
Evaluate complications due to guided bronchoscopic biopsy
Time frame: Confirmed by follow-up results at 1 year
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Chunnam National University Hwasun Hospital
Hwasun, South Korea
RECRUITINGInje University Ilsan Paik Hospital
Ilsan, South Korea
RECRUITINGGyeongsang National University Hospital
Jinju, South Korea
RECRUITINGSeoul National University Bundang Hospital
Seongnam-si, South Korea
RECRUITINGAsan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
RECRUITINGGangnam Severence Hospital
Seoul, South Korea
RECRUITINGHanyang University Hostpital
Seoul, South Korea
RECRUITINGThe Catholic University of Korea, Seoul, Korea
Seoul, South Korea
RECRUITING...and 1 more locations