Combined Application of EBUS and EUS in Lung Cancer

National Cancer Center, Korea162 enrolled

Overview

This study aims to investigate a diagnostic yield and performance characteristics according to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration (EUS-B-FNA) in the mediastinal staging of potentially operable lung cancer. EUS-FNA is a better tolerated procedure than EBUS-TBNA. Therefore, EUS-B-FNA can be the main procedure in a combined approach with EBUS-TBNA and EUS-B-FNA. In group A, the investigators perform EBUS-TBNA first and EUS-B-FNA is performed when necessary. In group B, EUS-B-FNA is first applied and EBUS-TBNA is performed when necessary. The hypothesis is that the diagnostic yield of the EUS centered procedure is as good as that of the EBUS centered procedure and the EUS centered procedure is more tolerable than the EBUS centered procedure. We evaluate diagnostic yields and performance characteristics of each group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

162

Conditions

Non Small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC) * Potentially operable patients Exclusion Criteria: * M1 disease * Inoperable T4 disease * Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT. * Confirmed supraclavicular lymph node metastasis * Pancoast tumors * Medically inoperable patients * Contraindications for bronchoscopy and esophageal endoscopy * Drug reaction to lidocaine, midazolam,fentanyl * Pregnancy * Ground glass-dominant nodule ( \< 3cm)

Outcomes

Primary Outcomes

Diagnostic accuracy

Time frame: When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months

Secondary Outcomes

Procedure time

Time frame: During and just after the procedure ; 5-60 minutes

Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia)

Time frame: During the procedure; 0-60 minutes

Degree of desaturation

Time frame: During the procedure; 0-60minutes

Discomfort by the procedure

Time frame: After the procedure ; 2-3hr

Number of participants with adverse Events (infection, bleeding requiring intervention, pneumothorax, or any complications requiring hospital admission)

Time frame: During and after the procedure; 0-2 weeks

Lymph node features

Time frame: During and after the procedure; 0-2hrs

Fentanyl/midazolam/lidocaine consumption

Time frame: After the procedure ; 1-2 hrs