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EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00119470
Recruitment Status : Completed
First Posted : July 13, 2005
Last Update Posted : December 28, 2007
Information provided by:
University Hospital, Ghent

Brief Summary:

This trial examines the role of EUS-FNA (Oesophageal Endoscopic Ultrasound with Fine Needle Aspiration) as an endoscopic technique for the mediastinal staging of patients with lung cancer.

Patients will be randomized to either conventional surgical technique or EUS-FNA.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: EUS-FNA Procedure: Conventional Surgical Technique Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer: A Randomized Trial
Study Start Date : February 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Percentage of surgical interventions avoided

Secondary Outcome Measures :
  1. Accuracy of EUS-FNA for mediastinal staging of lung cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with histological or cytological proof of non small cell lung cancer (NSCLC) or with a high clinical suspicion for lung cancer (but without pathologically confirmed diagnosis from the bronchoscopy or CT guided transthoracal biopsies) in whom the next step is normally a diagnostic or therapeutic surgical intervention
  • no distant metastases after routine clinical work up (PET is optional, not mandatory)
  • provision of a written informed consent
  • recent CT-scan of the thorax (<28 days before randomization date)
  • age 18 years or older
  • clinically fit for surgery

Exclusion Criteria:

  • proof of small cell lung cancer (SCLC) with CWU (bronchoscopy or CT guided transthoracal punction)
  • stage IV NSCLC
  • patients with a solitary pulmonary nodule (thus without enlarged mediastinal lymph nodes on CT and without mediastinal PET hot spots) : these do not require further mediastinal investigation
  • former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
  • other concomitant malignancies
  • reasons for which the patient is unable to swallow the EUS-instrument (e.g. zenker diverticulum, unexplained esophageal stenosis)
  • uncorrected coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00119470

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University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
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Principal Investigator: Kurt Tournoy, MD University Hospital, Ghent
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00119470    
Other Study ID Numbers: 2004/276
First Posted: July 13, 2005    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases