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Combined Application of EBUS and EUS in Lung Cancer

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ClinicalTrials.gov Identifier: NCT01385111
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : October 18, 2012
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Procedure: EUS-B-FNA followed by EBUS-TBNA Procedure: EBUS-TBNA followed by EUS-B-FNA Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
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 Start Date : June 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm A
EBUS centered
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.
Experimental: Arm B
EUS centered
Procedure: 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



Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months ]

Secondary Outcome Measures :
  1. Procedure time [ Time Frame: During and just after the procedure ; 5-60 minutes ]
  2. Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia) [ Time Frame: During the procedure; 0-60 minutes ]
  3. Degree of desaturation [ Time Frame: During the procedure; 0-60minutes ]
  4. Discomfort by the procedure [ Time Frame: After the procedure ; 2-3hr ]
  5. 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 ]
  6. Lymph node features [ Time Frame: During and after the procedure; 0-2hrs ]
  7. Fentanyl/midazolam/lidocaine consumption [ Time Frame: After the procedure ; 1-2 hrs ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385111


Locations
Korea, Republic of
National Cancer Center (NCC) Korea
Goyang, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Bin Hwangbo, MD, PhD Medical Doctor, Senior Researcher

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bin, Hwangbo, National Cancer center
ClinicalTrials.gov Identifier: NCT01385111     History of Changes
Other Study ID Numbers: NCC-EUSEBUS
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: June 2011

Keywords provided by National Cancer Center, Korea:
endobronchial ultrasound
endoscopic ultrasound
EBUS-TBNA
EUS-FNA
EUS-B-FNA
lung cancer
staging

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms