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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00886847
First received: April 21, 2009
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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.

Condition Intervention
Lymphadenopathy
Procedure: Lymph Node Needle Tissue Collections

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Specimen Adequacy and Diagnostic Agreement of Fine Needle Aspiration (FNA) VS. Fine Needle Capillary Sampling (FNC) of Endobronchial Ultrasound-Guided Biopsy of Mediastinal Lymph Nodes

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of times FNA and FNC agree on patient diagnosis (concordance) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: April 2009
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EBUS FNA vs FNC 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).
Other Names:
  • Fine Needle Aspiration
  • Fine Needle Capillary

Detailed Description:

Tissue Sample Collection:

If you agree to take part in this study, you will have your already scheduled endobronchial ultrasound-guided biopsy performed after you have been given a drug to make you sleep. You will be asked to sign a separate informed consent for the biopsy procedure.

During a standard of care biopsy procedure, there are normally 3-5 tissue sample collections performed. For the purposes of this study, you will have a total of 4 tissue collections performed during the biopsy procedure. Two tissue collections (2) using the FNC method, and 2 tissue collections using the FNA method.

If the first 4 tissue sample collections do not provide good enough tissue samples to perform the diagnosis, additional sample collections may be performed. If more samples are collected, these samples will not be used for the purposes of this study and will only be collected for diagnostic purposes.The sampling will be done by the pulmonologist who is performing your procedure.

The first 4 tissue samples that are collected for the purposes of this study will be examined to determine the quality of the sample as well as for diagnostic purposes.

Medical Record Information:

Information from your medical record will be collected 1 time for this study. The information collected will include information about your diagnosis, the number of radiation treatments you may have had, and additional information about your medical history. The information will be de-identified and stored in a research database on a password protected computer that only the study doctor and study staff will have access to.

Length of Study:

You will remain on study for the duration of biopsy procedure. After the biopsy has been performed, and your medical record information has been collected you will no longer be on study.

This is an investigational study. The endobronchial ultrasound-guided biopsy of the lymph nodes is FDA approved. Both methods of tissue collection (FNA and FNC) are FDA approved for the purposes of this study.

Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients 18 years or older
  2. Patients in which EBUS is indicated based on the suspicion of either benign or malignant disease in mediastinal and/or hilar lymph nodes. This will include patients who are in the hospital.

Exclusion Criteria:

1. patients under 18 years or younger

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886847

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77007
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Rodolfo C. Morice, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00886847     History of Changes
Other Study ID Numbers: 2009-0051
Study First Received: April 21, 2009
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lung
Lymphadenopathy
Enlarged hilar or/and mediastinal lymph adenopathy
Benign
Malignant
Mediastinal lymph nodes
Hilar lymph nodes
Fine Needle Aspiration
FNA
Fine Needle Capillary Sampling
FNC
Endobronchial Ultrasound-Guided Biopsy
EBUS
Tissue Sample
Suction

Additional relevant MeSH terms:
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014