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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00119470
First received: July 1, 2005
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

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
Endpoint Classification: Efficacy Study
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119470

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

Additional Information:
No publications provided by University Hospital, Ghent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00119470     History of Changes
Other Study ID Numbers: 2004/276
Study First Received: July 1, 2005
Last Updated: December 19, 2007
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014