Combined Application of EBUS and EUS in Lung Cancer

October 17, 2012 updated by: National Cancer Center, Korea

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center (NCC) Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy
Time Frame: When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months
When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Bin Hwangbo, MD, PhD, Medical Doctor, Senior Researcher

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (ESTIMATE)

June 29, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-EUSEBUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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