Lung Cancer
Conditions
Keywords
Electromagnetic Navigation Bronchoscopy, Guided Bronchoscopy, Diagnosis, Radial Endobronchial Ultrasound
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).
Interventions
DEVICEGuided bronchoscopy
It is performed when a pulmonary lesion with a possibility of malignancy is found on chest CT and histological diagnosis and differentiation are required.
Sponsors
Seoul National University Bundang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactYeon Wook Kim, MD., PhD
Outcome results
None listed