Combined Application of EBUS and EUS in Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01385111
First received: June 23, 2011
Last updated: October 17, 2012
Last verified: June 2011
  Purpose

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 Intervention
Non Small Cell Lung Cancer
Procedure: EUS-B-FNA followed by EBUS-TBNA
Procedure: EBUS-TBNA followed by EUS-B-FNA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Diagnostic accuracy [ Time Frame: When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Procedure time [ Time Frame: During and just after the procedure ; 5-60 minutes ] [ Designated as safety issue: No ]
  • Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia) [ Time Frame: During the procedure; 0-60 minutes ] [ Designated as safety issue: Yes ]
  • Degree of desaturation [ Time Frame: During the procedure; 0-60minutes ] [ Designated as safety issue: Yes ]
  • Discomfort by the procedure [ Time Frame: After the procedure ; 2-3hr ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Lymph node features [ Time Frame: During and after the procedure; 0-2hrs ] [ Designated as safety issue: No ]
  • Fentanyl/midazolam/lidocaine consumption [ Time Frame: After the procedure ; 1-2 hrs ] [ Designated as safety issue: Yes ]

Enrollment: 162
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by National Cancer Center, Korea

Additional 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
Study First Received: June 23, 2011
Last Updated: October 17, 2012
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014