CClinicalTrials.gg
CompletedNCT00119470Updated Dec 28, 2007

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

A Phase 2 interventional study of EUS-FNA and Conventional Surgical Technique in Lung Cancer, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-12-28.

Sponsored by University Hospital, Ghent · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer

Browse trials for

03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants

Interventions

  • ProcedureEUS-FNA
  • ProcedureConventional Surgical Technique
06

What researchers measure

Primary outcomes

  1. Percentage of surgical interventions avoided

Secondary outcomes

  1. Accuracy of EUS-FNA for mediastinal staging of lung cancer

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

References and documents

Publications

  • 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. PubMed 17962631 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00119470
Lead sponsor
University Hospital, Ghent
First posted
Jul 13, 2005
Start date
Feb 2005
Completion
Feb 2007
Last update
Dec 28, 2007

Study contacts

Kurt Tournoy, MD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion