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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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EUS-FNA

Intervention Type PROCEDURE

Conventional Surgical Technique

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Kurt Tournoy, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED

PMID: 17962631 (View on PubMed)

Other Identifiers

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2004/276

Identifier Type: -

Identifier Source: org_study_id