Enlarged Lymph Nodes (Excluding Infective)
Conditions
Brief summary
This study compares the yield of 19-gauge needles vs 21-gauge needles during EBUS TBNA procedures.
Detailed description
Endobronchial ultrasound-guided transbronchial needle aspirate (EBUS-TBNA) is a technique used to take samples of body tissue inside the chest without having to undergo an operation. During this procedure, a special telescope (called a bronchoscope) is inserted through the mouth into the airways. Ultrasound technology allows the doctor to see the structures just outside the airway. By being able to see the structures outside the airway, the doctor is able to safely pass a fine needle through the airway to take samples of abnormal tissue. EBUS-TBNA is used to take samples of tissue from the mediastinum. The mediastinum is the part of the chest between the lungs, and contains the heart, gullet, windpipe and lymph nodes. This area of the body is usually difficult to access without open surgery, hence the use of EBUS-TBNA. EBUS-TBNA may be used to investigate enlarged lymph nodes. This may be due to tuberculosis, sarcoidosis or cancer. Currently, smaller 21-gauge and larger 19-gauge needles are used during the EBUS-TBNA procedure at Regions Hospital. The purpose of this study is to find out which needle is better in finding the explanation for the enlarged lymph nodes, and any follow up procedures that may be necessary if the investigators are unable to get enough tissue during the EBUS-TBNA procedure (surgical sampling, radiological sampling, and/or follow-up imaging).
Interventions
DEVICEEBUS TBNA
All patients undergo EBUS TBNA with two needle sizes
Sponsors
HealthPartners Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective diagnostic accuracy study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Able to provide informed consent * Referred for EBUS TBNA sampling at Regions Hospital
Exclusion criteria
* On therapeutic warfarin, Plavix, or ticagrelor in the past 5 days * INR\>1.8 or platelets \<50K
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield | 6 months | Diagnostic yield refers to the proportion of tissue samples collected by each needle (19 gauge vs 21 gauge) that were of sufficient quantity and quality to yield (i.e. produce) an accurate diagnosis for the patient's enlarged lymph nodes. Characterization of diagnostic category (true positive, true negative, false negative, false positive) were made by comparing the patient's presumed diagnosis/initial indication for presentation in comparison to their final diagnosis as determined by a combination of pathological findings of EBUS-TBNA, follow up imaging, surgical sampling, or clinical follow up. The diagnostic yield of each needles was reported as a ratio of true positives and true negatives added together, divided by the total number of lymph nodes sampled (141). Diagnostic yield of 19-gauge needle: 89.4% Diagnostic yield of 21-gauge needled: 88.7% |
Countries
United States
Participant flow
Recruitment details
60 consecutive patients referred for EBUS-TBNA sampling between July 2018 and January 2019 were enrolled after providing written consent.
Pre-assignment details
A total of 144 lymph nodes were sampled from the 60 enrolled. Of these, 3 lymph nodes were excluded from analysis due to protocol deviations (two were only sampled with one needle and the third underwent one pass before the provider decided to change sites).
Participants by arm
| Arm | Count |
|---|---|
| Sampling With 19-gauge and 21-gauge All patients will be allocated to the same arm. All patients will have EBUS TBNA done with both 19-gauge and 21-gauge needles during the procedure.
EBUS TBNA: All patients undergo EBUS TBNA with two needle sizes | 60 |
| Sampling With 19-gauge and 21-gauge All patients will be allocated to the same arm. All patients will have EBUS TBNA done with both 19-gauge and 21-gauge needles during the procedure.
EBUS TBNA: All patients undergo EBUS TBNA with two needle sizes | 141 |
| Total | 201 |
Baseline characteristics
| Characteristic | Sampling With 19-gauge and 21-gauge |
|---|---|
| Age, Customized Age Distribution Patients < 18 | 0 Participants |
| Age, Customized Age Distribution Patients >/= 18 | 60 Participants |
| Region of Enrollment United States | 60 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 1 / 30 |
| other Total, other adverse events | 3 / 30 | 4 / 30 |
| serious Total, serious adverse events | 1 / 30 | 2 / 30 |
Outcome results
Primary
Diagnostic Yield
Diagnostic yield refers to the proportion of tissue samples collected by each needle (19 gauge vs 21 gauge) that were of sufficient quantity and quality to yield (i.e. produce) an accurate diagnosis for the patient's enlarged lymph nodes. Characterization of diagnostic category (true positive, true negative, false negative, false positive) were made by comparing the patient's presumed diagnosis/initial indication for presentation in comparison to their final diagnosis as determined by a combination of pathological findings of EBUS-TBNA, follow up imaging, surgical sampling, or clinical follow up. The diagnostic yield of each needles was reported as a ratio of true positives and true negatives added together, divided by the total number of lymph nodes sampled (141). Diagnostic yield of 19-gauge needle: 89.4% Diagnostic yield of 21-gauge needled: 88.7%
Time frame: 6 months
Population: All 141 lymph nodes included in the final analysis were sampled by both the 19-guage and 21-guage needle. Participants were randomized to a particular ordering of the needles (either the 19-gauge or 21-guage needle would be used to sample lymph nodes sites first, followed by which ever remaining needle had not been used).
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| 19-Gauge Needle | Diagnostic Yield | True Positives | 69 lymph nodes |
| 19-Gauge Needle | Diagnostic Yield | True Negatives | 57 lymph nodes |
| 19-Gauge Needle | Diagnostic Yield | False Negatives + False Positives (Not included in calculation of diagnostic yield) | 15 lymph nodes |
| 21-Gauge Needle | Diagnostic Yield | True Positives | 68 lymph nodes |
| 21-Gauge Needle | Diagnostic Yield | True Negatives | 57 lymph nodes |
| 21-Gauge Needle | Diagnostic Yield | False Negatives + False Positives (Not included in calculation of diagnostic yield) | 16 lymph nodes |
Primary
Diagnostic Yield
Diagnostic yield refers to the proportion of tissue samples collected by each needle (19 gauge vs 21 gauge) that were of sufficient quantity and quality to yield (i.e. produce) an accurate diagnosis for the patient's enlarged lymph nodes. Characterization of diagnostic category (true positive, true negative, false negative, false positive) were made by comparing the patient's presumed diagnosis/initial indication for presentation in comparison to their final diagnosis as determined by a combination of pathological findings of EBUS-TBNA, follow up imaging, surgical sampling, or clinical follow up. The diagnostic yield of each needles was reported as a ratio of true positives and true negatives added together, divided by the total number of lymph nodes sampled (141).
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| 19-Gauge Needle | Diagnostic Yield | 126 lymph nodes |
| 21-Gauge Needle | Diagnostic Yield | 125 lymph nodes |