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Comparison of Endobronchial Ultrasound-Guided Biopsy Using Fine Needle Aspiration Versus Fine Needle Capillary Sampling

NCT00886847 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-02-19

No results posted yet for this study

Summary

Primary objective:

* To estimate the degree of agreement in diagnosis of cytologic samples from mediastinal lymph nodes obtained by Endobronchial Ultrasound (EBUS)-guided Fine Needle Capillary Sampling (FNC) versus Fine Needle Aspiration (FNA).

Secondary objective:

* To compare the quality of cytologic samples from mediastinal lymph nodes obtained by EBUS-guided FNC versus FNA. The quality of the samples will be assessed initially by MDACC on-site cytology technicians, and then corroborated by physicians in the department of cytology. This assessment will be performed utilizing the Mair's score 3. The score consists of a 0-10 scale: 1-2= poor; 3-6=good; 7-10=superior.

Conditions

  • Lymphadenopathy

Interventions

PROCEDURE

Lymph Node Needle Tissue Collections

Total of two lymph nodes sampled per patient. Four biopsies will be taken from each lymph node. Two with suction (FNA) and two without suction (FNC).

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Rodolfo C. Morice, MD · UT MD 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
2009-04-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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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 NCT00886847 on ClinicalTrials.gov