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Combined Application of EBUS and EUS in Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EUS-B-FNA followed by EBUS-TBNA
EBUS-TBNA followed by EUS-B-FNA
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non Small Cell Lung Cancer focused on measuring endobronchial ultrasound, endoscopic ultrasound, EBUS-TBNA, EUS-FNA, EUS-B-FNA, lung cancer, staging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • National Cancer Center (NCC) Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

EBUS centered

EUS centered

Outcomes

Primary Outcome Measures

Diagnostic accuracy

Secondary Outcome Measures

Procedure time
Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia)
Degree of desaturation
Discomfort by the procedure
Number of participants with adverse Events (infection, bleeding requiring intervention, pneumothorax, or any complications requiring hospital admission)
Lymph node features
Fentanyl/midazolam/lidocaine consumption

Full Information

First Posted
June 23, 2011
Last Updated
October 17, 2012
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01385111
Brief Title
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

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
endobronchial ultrasound, endoscopic ultrasound, EBUS-TBNA, EUS-FNA, EUS-B-FNA, lung cancer, staging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
EBUS centered
Arm Title
Arm B
Arm Type
Experimental
Arm Description
EUS centered
Intervention Type
Procedure
Intervention Name(s)
EUS-B-FNA followed by EBUS-TBNA
Intervention Description
EUS-B-FNA will be performed followed by EBUS-TBNA when additional needle aspiration is necessary after EBUS-TBNA.
Intervention Type
Procedure
Intervention Name(s)
EBUS-TBNA followed by EUS-B-FNA
Intervention Description
EBUS-TBNA will be performed followed by EUS-B-FNA when additional needle aspiration is necessary after EUS-B-FNA
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Time Frame
When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months
Secondary Outcome Measure Information:
Title
Procedure time
Time Frame
During and just after the procedure ; 5-60 minutes
Title
Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia)
Time Frame
During the procedure; 0-60 minutes
Title
Degree of desaturation
Time Frame
During the procedure; 0-60minutes
Title
Discomfort by the procedure
Time Frame
After the procedure ; 2-3hr
Title
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
Title
Lymph node features
Time Frame
During and after the procedure; 0-2hrs
Title
Fentanyl/midazolam/lidocaine consumption
Time Frame
After the procedure ; 1-2 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Hwangbo, MD, PhD
Organizational Affiliation
Medical Doctor, Senior Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center (NCC) Korea
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24172712
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.
Results Reference
derived

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Combined Application of EBUS and EUS in Lung Cancer

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