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

NCT00741247 | Completed DMC

• 1 other identifier: NCCCTS-08-332
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

staging; Endobronchial ultrasound; Endoscopic ultrasound

Outcome Measures

Primary Outcomes (1)

• The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone

  June 2009

Secondary Outcomes (1)

• The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA.

  June 2009

Interventions

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

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

NCCKorea

Gyeonggi-do, South Korea

Location

Related Publications (1)

• 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.

  PMID: 20348194 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration; Bronchoscopes

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: June 24, 2009

Record last verified: 2009-06

Locations

KR (1)