Not Signed In -
Alexanders Technique |
Alexander Technique |
Clinical Trial: EUS-FNA in the Pre-Operative Evaluation of Patients with Lung Cancer
This study is currently recruiting patients.
|
Purpose
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 | Intervention | Phase |
|---|---|---|
| Lung Cancer | Procedure: EUS-FNA Procedure: Conventional Surgical Technique | Phase III |
MedlinePlus related topics: Lung Cancer
Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: EUS-FNA in the Pre-Operative Evaluation of Patients with Lung Cancer: a Randomized Multicenter Trial
Further Study Details:
Primary Outcomes: Percentage of surgical interventions avoided
Secondary Outcomes: Accuracy of EUS-FNA for mediastinal staging of lung cancer
Expected Total Enrollment: 74
Secondary Outcomes: Accuracy of EUS-FNA for mediastinal staging of lung cancer
Expected Total Enrollment: 74
Study start: February 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00119470
Kurt Tournoy, MD 0032/9/240.28.16 kurt.tournoy@ugent.be
Belgium
University Hospital Ghent, Ghent, 9000, Belgium; Recruiting
Kurt Tournoy, MD 0032/9/240.28.16 kurt.tournoy@ugent.be
Study chairs or principal investigators
Kurt Tournoy, MD, Principal Investigator, University Hospital Ghent
More Information
Study ID Numbers: 2004/276
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 12, 2005
ClinicalTrials.gov Identifier: NCT00119470
Health Authority: Belgium: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 12, 2005
ClinicalTrials.gov Identifier: NCT00119470
Health Authority: Belgium: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26
email this page
print this page
bookmark this page
feedback on this page
