NCT01385111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

October 18, 2012

Status Verified

June 1, 2011

Enrollment Period

8 months

First QC Date

June 23, 2011

Last Update Submit

October 17, 2012

Conditions

Non Small Cell Lung Cancer

Keywords

endobronchial ultrasoundendoscopic ultrasoundEBUS-TBNAEUS-FNAEUS-B-FNAlung cancerstaging

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months

Secondary Outcomes (7)

  • Procedure time

    During and just after the procedure ; 5-60 minutes

  • Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia)

    During the procedure; 0-60 minutes

  • Degree of desaturation

    During the procedure; 0-60minutes

  • Discomfort by the procedure

    After the procedure ; 2-3hr

  • Number of participants with adverse Events (infection, bleeding requiring intervention, pneumothorax, or any complications requiring hospital admission)

    During and after the procedure; 0-2 weeks

  • +2 more secondary outcomes

Study Arms (2)

Arm A

ACTIVE COMPARATOR

EBUS centered

Procedure: EUS-B-FNA followed by EBUS-TBNA

Arm B

EXPERIMENTAL

EUS centered

Procedure: EBUS-TBNA followed by EUS-B-FNA

Interventions

EUS-B-FNA followed by EBUS-TBNAPROCEDURE

EUS-B-FNA will be performed followed by EBUS-TBNA when additional needle aspiration is necessary after EBUS-TBNA.

Arm A
EBUS-TBNA followed by EUS-B-FNAPROCEDURE

EBUS-TBNA will be performed followed by EUS-B-FNA when additional needle aspiration is necessary after EUS-B-FNA

Arm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
  • Potentially operable patients

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center (NCC) Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 24172712DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bin Hwangbo, MD, PhD

    Medical Doctor, Senior Researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 29, 2011

Study Start

June 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

October 18, 2012

Record last verified: 2011-06

Locations

KR(1)