Combined Application of EBUS and EUS in Lung Cancer

Not Applicable

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Procedure: EBUS-TBNA followed by EUS-B-FNA; Procedure: EUS-B-FNA followed by EBUS-TBNA

• Registration Number: NCT01385111
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-06
• Study Start: 2011-06
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-29
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-10-17
• Last Update Posted: 2012-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	EBUS-TBNA followed by EUS-B-FNA	EUS centered
Arm A	EUS-B-FNA followed by EBUS-TBNA	EBUS centered

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Cancer Center (NCC) Korea; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of