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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119470
• Other study ID #: 2004/276
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2005
• Last updated: December 19, 2007
• Start date: February 2005
• Est. completion date: February 2007

Study information

• Verified date: December 2007
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• EUS-FNA

• Conventional Surgical Technique

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of surgical interventions avoided
Secondary	Accuracy of EUS-FNA for mediastinal staging of lung cancer

External Links

•   Website University Hospital Ghent