Mediastinal Staging of Lung Cancer With EBUS-TBNA and EUS-B-FNA

NCT ID: NCT00741247

Last Updated: 2009-06-24

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to find a role of EUS-B-FNA in the mediastinal staging of potentially operable lung cancer. The investigators perform EBUS-TBNA and EUS-B-FNA on potentially operable lung cancer patients. The investigators perform EBUS(+/- TBNA) and EUS-B (ultrasonographic examination through the esophagus) on all subjects. EUS-B-FNA will be performed on inaccessible nodes or difficult nodes to be sampled by EBUS-TBNA. Additional diagnostic values of EUS-B-FNA as compared to EBUS-TBNA alone will be estimated.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)

EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions. EUS-FNA is a procedure to obtain samples through the esophagus under real-time ultrasound guidance. In this study, EUS-FNA will be applied using a ultrasonic bronchoscope (EUS-B-FNA).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

After staging work-up for NSCLC, including bronchoscopy,CT of the chest and upper abdomen, integrated PET/CT and brain MRI (and/or bone scan)

* 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
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, Korea

Locations

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NCCKorea

Gyeonggi-do, , South Korea

Site Status

Countries

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South Korea

References

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Hwangbo B, Lee GK, Lee HS, Lim KY, Lee SH, Kim HY, Lee HS, Kim MS, Lee JM, Nam BH, Zo JI. Transbronchial and transesophageal fine-needle aspiration using an ultrasound bronchoscope in mediastinal staging of potentially operable lung cancer. Chest. 2010 Oct;138(4):795-802. doi: 10.1378/chest.09-2100. Epub 2010 Mar 26.

Reference Type DERIVED
PMID: 20348194 (View on PubMed)

Other Identifiers

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NCCCTS-08-332

Identifier Type: -

Identifier Source: org_study_id

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