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

Sponsor
University Hospital, Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT00119470
Collaborator
(none)
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Study Details

Study Description

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
  • Procedure: EUS-FNA
  • Procedure: Conventional Surgical Technique
Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 1, 2005
Actual Study Completion Date :
Feb 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Percentage of surgical interventions avoided []

Secondary Outcome Measures

  1. Accuracy of EUS-FNA for mediastinal staging of lung cancer []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Locations

Site City State Country Postal Code
1 University Hospital Ghent Ghent Belgium 9000

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

  • Principal Investigator: Kurt Tournoy, MD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00119470
Other Study ID Numbers:
  • 2004/276
First Posted:
Jul 13, 2005
Last Update Posted:
Dec 28, 2007
Last Verified:
Dec 1, 2007
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2007