Clinical trial NCT01385111: Combined Application of EBUS and EUS in Lung Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: endobronchial ultrasound
endoscopic ultrasound
EBUS-TBNA
EUS-FNA
EUS-B-FNA
lung cancer
staging
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2011-06-29
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months
Secondary outcomes:
measure: Procedure time
timeFrame: During and just after the procedure ; 5-60 minutes
measure: Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia)
timeFrame: During the procedure; 0-60 minutes
measure: Degree of desaturation
timeFrame: During the procedure; 0-60minutes
measure: Discomfort by the procedure
timeFrame: After the procedure ; 2-3hr
measure: Number of participants with adverse Events (infection, bleeding requiring intervention, pneumothorax, or any complications requiring hospital admission)
timeFrame: During and after the procedure; 0-2 weeks
measure: Lymph node features
timeFrame: During and after the procedure; 0-2hrs
measure: Fentanyl/midazolam/lidocaine consumption
timeFrame: After the procedure ; 1-2 hrs
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center (NCC) Korea
state: Gyeonggi-do
Study officials:
affiliation: Medical Doctor, Senior Researcher
name: Bin Hwangbo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang HJ, Hwangbo B, Lee GK, Nam BH, Lee HS, Kim MS, Lee JM, Zo JI, Lee HS, Han JY. EBUS-centred versus EUS-centred mediastinal staging in lung cancer: a randomised controlled trial. Thorax. 2014 Mar;69(3):261-8. doi: 10.1136/thoraxjnl-2013-203881. Epub 2013 Oct 30.