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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00886847

Collaborator

(none)

120

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

N/A

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 :

Apr 1, 2009

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of times FNA and FNC agree on patient diagnosis (concordance) [2 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients 18 years or older
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.