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Endobronchial Ultrasound Versus Mediastinoscopy in Patients With Non-Small Cell Lung Cancer (NSCLC)

NCT00559611 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-03-29

No results posted yet for this study

Summary

The goal of this clinical research study is to compare 2 different methods for checking lymph glands (in the middle of the chest) for cancer cells.

Objectives:

The aim of this prospective study is to determine the staging accuracy of endobronchial ultrasound guided fine needle aspiration biopsy of mediastinal lymph nodes compared to the 'gold standard', mediastinoscopy, in patients with clinical Stage IIIA non-small cell lung cancer.

Primary Objective:

To determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EBUS-FNA and mediastinoscopy in identifying mediastinal nodal metastases.

Secondary Objectives:

To estimate quantitative and qualitative differences regarding sampling of mediastinal nodes (number and location of nodes biopsied, number and location of positive nodes, extracapsular extension, ability to biopsy contralateral nodes).

To determine the frequency of change of planned therapeutic management resulting from outcome of EBUS-FNA and mediastinoscopy.

To determine procedure related complications. To perform analysis of cost between EBUS-FNA and mediastinoscopy.

Conditions

Interventions

PROCEDURE

Endobronchial Ultrasound

A small flexible scope is passed down the windpipe. Samples of lymph gland tissue will be collected through a tiny needle that is passed through the scope.

PROCEDURE

Mediastinoscopy

Performed if a tumor is not found on the opposite side of your chest from another tumor by the EBUS.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David C. Rice, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-19
Primary Completion
2018-03-22
Completion
2018-03-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00559611 on ClinicalTrials.gov