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Completed

NCT Number: NCT00741247

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NCCKorea

Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

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

    Time frame: June 2009

Secondary outcomes

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

    Time frame: June 2009

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

Minimally Invasive Mediastinal Staging of Potentially Operable Lung Cancer With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration(EBUS-TBNA) and Transesophageal Aspiration Using Ultrasonic Bronchoscope (EUS-B-FNA)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 26, 2008
Registry last updated
Jun 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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