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

Ghent University Hospital (UZ)

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Procedure: Conventional Surgical Technique

Procedure: EUS-FNA

Study type

Interventional

Funder types

Other

Identifiers

NCT00119470

2004/276

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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