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

This study has been completed.

First Received: July 1, 2005 Last Updated: December 19, 2007 History of Changes

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00119470

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 II

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer: A Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

U.S. FDA Resources

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:

Website University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided by University Hospital, Ghent

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Tournoy KG, De Ryck F, Vanwalleghem LR, Vermassen F, Praet M, Aerts JG, Van Maele G, van Meerbeeck JP. Endoscopic ultrasound reduces surgical mediastinal staging in lung cancer: a randomized trial. Am J Respir Crit Care Med. 2008 Mar 1;177(5):531-5. Epub 2007 Oct 25.

Study ID Numbers:	2004/276
Study First Received:	July 1, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00119470 History of Changes
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on September 09, 2009