Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
University Hospital, Ghent Identifier:
First received: July 1, 2005
Last updated: December 19, 2007
Last verified: December 2007

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 Intervention Phase
Lung Cancer
Procedure: EUS-FNA
Procedure: Conventional Surgical Technique
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer: A Randomized Trial

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Percentage of surgical interventions avoided

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

Estimated Enrollment: 40
Study Start Date: February 2005
Study Completion Date: February 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00119470

University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Principal Investigator: Kurt Tournoy, MD University Hospital, Ghent
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00119470     History of Changes
Other Study ID Numbers: 2004/276
Study First Received: July 1, 2005
Last Updated: December 19, 2007

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on April 28, 2017