Combined Application of EBUS and EUS in Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385111
• Other study ID #: NCC-EUSEBUS
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: October 17, 2012
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: June 2011
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Procedure:
• EUS-B-FNA followed by EBUS-TBNA
EUS-B-FNA will be performed followed by EBUS-TBNA when additional needle aspiration is necessary after EBUS-TBNA.
• EBUS-TBNA followed by EUS-B-FNA
EBUS-TBNA will be performed followed by EUS-B-FNA when additional needle aspiration is necessary after EUS-B-FNA

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center (NCC) Korea	Goyang	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy		When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months	No
Secondary	Procedure time		During and just after the procedure ; 5-60 minutes	No
Secondary	Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia)		During the procedure; 0-60 minutes	Yes
Secondary	Degree of desaturation		During the procedure; 0-60minutes	Yes
Secondary	Discomfort by the procedure		After the procedure ; 2-3hr	Yes
Secondary	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	Yes
Secondary	Lymph node features		During and after the procedure; 0-2hrs	No
Secondary	Fentanyl/midazolam/lidocaine consumption		After the procedure ; 1-2 hrs	Yes