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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
EUS-FNA
Conventional Surgical Technique
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Ghent

Outcomes

Primary Outcome Measures

Percentage of surgical interventions avoided

Secondary Outcome Measures

Accuracy of EUS-FNA for mediastinal staging of lung cancer

Full Information

First Posted
July 1, 2005
Last Updated
December 19, 2007
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00119470
Brief Title
EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer
Official Title
EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
EUS-FNA
Intervention Type
Procedure
Intervention Name(s)
Conventional Surgical Technique
Primary Outcome Measure Information:
Title
Percentage of surgical interventions avoided
Secondary Outcome Measure Information:
Title
Accuracy of EUS-FNA for mediastinal staging of lung cancer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Tournoy, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
17962631
Citation
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.
Results Reference
derived
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent

Learn more about this trial

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

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