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

Not Applicable

Withdrawn

• Conditions: Non Small Cell Lung Cancer
• Interventions: Procedure: EBUS-TBNA, integrated PET/CT

• Registration Number: NCT00859742
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EBUS-TBNA	EBUS-TBNA, integrated PET/CT	-

Primary Outcome Measures

Name	Time	Method
The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer.	1.5 years

Secondary Outcome Measures

Name	Time	Method
The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer	1.5 years
The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy	1.5 years

Trial Locations

Locations (1)

NCCKorea; 🇰🇷 Goyang, Gyeonggi-do, Korea, Republic of