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

NCT00119470 | Completed Phase 2

• 1 other identifier: 2004/276
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of surgical interventions avoided

Secondary Outcomes (1)

• Accuracy of EUS-FNA for mediastinal staging of lung cancer

Interventions

EUS-FNA PROCEDURE

Conventional Surgical Technique PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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. doi: 10.1164/rccm.200708-1241OC. Epub 2007 Oct 25.

  PMID: 17962631 DERIVED

Related Links

• Website University Hospital Ghent

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Kurt Tournoy, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 13, 2005
• Study Start: February 1, 2005
• Study Completion: February 1, 2007
• Last Updated: December 28, 2007

Record last verified: 2007-12

Locations

BE (1)