EUS-FNA in the Pre-Operative Evaluation of Patients With... | NCT00119470

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

NCT00119470

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Dec 28, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Lung Cancer

Interventions

EUS-FNA
Conventional Surgical Technique

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Not provided

Completion Date

Feb 2007Actual

First Submitted Date

Jul 1, 2005

First Submission Date that Met QC Criteria

Jul 2, 2005

First Posted Date

Jul 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2007

Last Update Posted Date

Dec 28, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
Percentage of surgical interventions avoided

Measure	Description	Time Frame
Accuracy of EUS-FNA for mediastinal staging of lung cancer

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kurt Tournoy, MD	University Hospital, Ghent	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17962631	Derived	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.

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D044963	Biopsy, Fine-Needle
D001707	Biopsy, Needle
D001706	Biopsy
D003581	Cytodiagnosis

Name	Type	Description	Arm Group Labels	Other Names
EUS-FNA	Procedure
Conventional Surgical Technique	Procedure