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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00886847
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : February 19, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Lymphadenopathy Procedure: Lymph Node Needle Tissue Collections Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : April 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of times FNA and FNC agree on patient diagnosis (concordance) [ Time Frame: 2 Years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00886847

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00886847     History of Changes
Other Study ID Numbers: 2009-0051
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: August 2012

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

Additional relevant MeSH terms:
Lymphatic Diseases