Comparison of Endobronchial Ultrasound-Guided Biopsy Using Fine Needle Aspiration Versus Fine Needle Capillary Sampling
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2009 |
| End Date: | August 2012 |
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
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.
- 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.
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.
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.
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
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