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Combined Application of EBUS and EUS in Lung Cancer

NCT ID: NCT01385111

Last Updated: 2012-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Keywords

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endobronchial ultrasound endoscopic ultrasound EBUS-TBNA EUS-FNA EUS-B-FNA lung cancer staging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm A

EBUS centered

Group Type ACTIVE_COMPARATOR

EUS-B-FNA followed by EBUS-TBNA

Intervention Type PROCEDURE

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

Arm B

EUS centered

Group Type EXPERIMENTAL

EBUS-TBNA followed by EUS-B-FNA

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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National Cancer center

Principal Investigators

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Bin Hwangbo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Doctor, Senior Researcher

Locations

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National Cancer Center (NCC) Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 24172712 (View on PubMed)

Other Identifiers

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NCC-EUSEBUS

Identifier Type: -

Identifier Source: org_study_id