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Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging: a Randomized Clinical Trial

18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

Complete Echo-Endoscopic Staging of Lung Cancer vs Surgical Staging: a Randomized Clinical Trial

Inclusion Criteria:

- Consecutive patients with NSCLC or with a clinical suspicion for lung cancer in whom
mediastinal lymph node invasion (either N2 or N3) is suspected based on the available
thoracic imaging

- Pending the results of the mediastinal staging, the patient is otherwise considered a
candidate for a surgical treatment with the intention to cure (this is a resectable

- The patient is clinically fit for diagnostic surgery (this is an operable patient)

- No distant metastasis after routine clinical work up

- Provision of a written informed consent

Exclusion Criteria:

- Former therapy (chemotherapy or radiotherapy or surgery) for lung cancer

- Reasons because of which the patient is unable to swallow the EUS-instrument (e.g.
Zenker Divertikel, unexplained esophageal stenosis) or because of which the patient
is unable to undergo a bronchoscopy

- Patients who, based on available thoracic imaging, are unlikely to be staged
accurately by any surgical staging procedure (mediastinoscopy/ - tomy, VATS)

- Respiratory insufficiency or other contra-indications for bronchoscopy

- Concurrent other malignancies

- Uncorrected coagulopathy

- Study cannot be discussed with the patient (e.g. mental disorder)

Type of Study:


Study Design:

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

Outcome Measure:

We hypothesize that the combination of EUS and EBUS in an out-patient one-session setting is more sensitive for the detection of locally advanced disease (N2/N3) compared to surgical staging (standard of care)

Principal Investigator

Kurt Tournoy, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent


Belgium: Institutional Review Board

Study ID:




Start Date:

January 2007

Completion Date:

April 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • (suspected) Non Small Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms