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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00119470

Enrollment

Registered

2005-07-13

Start date

2005-02-28

Completion date

2007-02-28

Last updated

2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

PROCEDUREEUS-FNA

PROCEDUREConventional Surgical Technique

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Percentage of surgical interventions avoided	—

Secondary

Measure	Time frame
Accuracy of EUS-FNA for mediastinal staging of lung cancer	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026