Combined Application of EBUS and EUS in Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Combined Application of EBUS-TBNA and EUS-B-FNA in Mediastinal Staging of Lung Cancer; EBUS-TBNA Centered Procedure vs. EUS-B-FNA Centered Procedure, a Randomized Study.

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Procedure: EUS-B-FNA followed by EBUS-TBNA
* Procedure: EBUS-TBNA followed by EUS-B-FNA


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>EBUS centered | Procedure: EUS-B-FNA followed by EBUS-TBNA<br>* EUS-B-FNA will be performed followed by EBUS-TBNA when additional needle aspiration is necessary after EBUS-TBNA.<br>|
| Experimental: Arm B<br>EUS centered | Procedure: EBUS-TBNA followed by EUS-B-FNA<br>* EBUS-TBNA will be performed followed by EUS-B-FNA when additional needle aspiration is necessary after EUS-B-FNA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy |  | When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time |  | During and just after the procedure ; 5-60 minutes | 
| Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia) |  | During the procedure; 0-60 minutes | 
| Degree of desaturation |  | During the procedure; 0-60minutes | 
| Discomfort by the procedure |  | After the procedure ; 2-3hr | 
| Number of participants with adverse Events (infection, bleeding requiring intervention, pneumothorax, or any complications requiring hospital admission) |  | During and after the procedure; 0-2 weeks | 
| Lymph node features |  | During and after the procedure; 0-2hrs | 
| Fentanyl/midazolam/lidocaine consumption |  | After the procedure ; 1-2 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endobronchial ultrasound, endoscopic ultrasound, EBUS-TBNA, EUS-FNA, EUS-B-FNA, lung cancer, staging