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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT00119470
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Procedure: EUS-FNA; Procedure: Conventional Surgical Technique	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer: A Randomized Trial
• Study Start Date: Feb 1, 2005
• Actual Study Completion Date: Feb 1, 2007

Outcome Measures

Primary Outcome Measures

1. Percentage of surgical interventions avoided []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Kurt Tournoy, MD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website University Hospital Ghent

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00119470
• Other Study ID Numbers: 2004/276
• First Posted: Jul 13, 2005
• Last Update Posted: Dec 28, 2007
• Last Verified: Dec 1, 2007

• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Dec 28, 2007