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

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00119470
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-07-01
• Study First Submitted QC: 2005-07-02
• Study First Posted: 2005-07-13
• Study Completion: 2007-02
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of surgical interventions avoided

Secondary Outcome Measures

Name	Time	Method
Accuracy of EUS-FNA for mediastinal staging of lung cancer

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium