Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

Seoul National University

Status: Enrolling

Conditions: Lung Cancer

Treatments: Device: Guided bronchoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT05804786

K-ORIENT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,240 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,240 participants in 1 patient group

single group

Description:

Patients with peripheral pulmonary lesions which require histological differentiation because of the possibility of malignancy, and a biopsy can be attempted through guided bronchoscopy

Treatment:

Device: Guided bronchoscopy