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EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer: A Randomized Trial

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer: A Randomized Trial

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Percentage of surgical interventions avoided

Principal Investigator

Kurt Tournoy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent


Belgium: Institutional Review Board

Study ID:




Start Date:

February 2005

Completion Date:

February 2007

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms