Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) for Mediastinal Re-staging of Non-small Cell Lung Cancer(NSCLC)

NCT ID: NCT00859742

Last Updated: 2018-04-02

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-08-31

Brief Summary

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The aim of this study is to determine the diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in patients with non-small cell lung cancer.

Primary objective:

1\. To determine the sensitivity, specificity, positive predictive value, negative predictive value and the accuracy of EBUS-TBNA in the detection of mediastinal metastasis in mediastinal re-staging after induction treatment.

Secondary objectives:

1. To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal re-staging
2. To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
3. To determine procedure related complications

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EBUS-TBNA

Group Type EXPERIMENTAL

EBUS-TBNA, integrated PET/CT

Intervention Type PROCEDURE

EBUS-TBNA and integrated PET/CT will be performed for patients with non-small cell lung cancer after induction therapy. PET/CT will be performed before EBUS-TBNA. Negative findings of EBUS-TBNA will be evaluated by surgery.

Interventions

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EBUS-TBNA, integrated PET/CT

EBUS-TBNA and integrated PET/CT will be performed for patients with non-small cell lung cancer after induction therapy. PET/CT will be performed before EBUS-TBNA. Negative findings of EBUS-TBNA will be evaluated by surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Histologically proven non-small cell lung cancer
* Patients who have initially histologically proven N2 disease (Stage IIIA)
* Patients who underwent induction treatment (chemotherapy or chemoradiation therapy) and are considred for surgery
* Written informed consent

Exclusion Criteria

* Contraindications for bronchoscopy
* Medically inoperable patients
* Patients who are found to have M1 disease, inoperable T4 disease or supraclavicular metastasis after induction treatment
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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Bin Hwangbo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bin Hwangbo, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Goyang, Gyeonggi-do, Korea, Republic of

Locations

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NCCKorea

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NCCTS-06-211

Identifier Type: -

Identifier Source: org_study_id

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