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This study compares the yield of 19-gauge needles vs 21-gauge needles during EBUS TBNA procedures.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sampling with 19-gauge and 21-gauge | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBUS TBNA | Device | All patients undergo EBUS TBNA with two needle sizes |
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| Measure | Description | Time Frame |
|---|---|---|
| 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% | 6 months |
| 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). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Firas S Elmufdi, MBBS | Regions Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
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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).
60 consecutive patients referred for EBUS-TBNA sampling between July 2018 and January 2019 were enrolled after providing written consent.
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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% | 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). | Posted | Count of Units | lymph nodes | 6 months | lymph nodes | lymph nodes |
Adverse event data was collected from the time the patient signed the consent form (i.e. immediately prior to the Endobronchial ultrasound (EBUS) transbronchial needle aspiration (TBNA) procedure), to the point at which the results of the confirmed and a final diagnosis was reported to the participant. Although the follow-up period varied by participant, the average length of time over which adverse events tracked and reported was 6 months.
Adverse events could not be reported per intervention (i.e., 19G versus 21G). The "passes" made on each lymph node using both gauge needles occurred in such close proximity to one other (on the order of seconds) that it would be impossible to determine what adverse events were related to which gauge needle. The adverse events listed relate to the overall bronchoscopic-biopsy procedure rather than to the size of the needle used during the biopsies.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 19-Gauge Needle Used First | Patients in this arm had their lymph nodes sampled with the 19-gauge needle first, followed by the 21-gauge needle. All patients were sampled by both needles; randomization and group arm assignment controlled for the order in which the needles were used. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient died during follow-up period as a result of respiratory failure secondary to underlying small cell lung cancer (a condition present at baseline). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Three patients noted to have mild hypoxia following procedure. Two resolved; one patient left against medical advise after being asked to stay under observation for low O2 sats |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meghan O'Brien / Study Coordinator | Regions Hospital | 612-437-1141 | meghan.e.obrien@healthpartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2018 | Sep 16, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072281 | Lymphadenopathy |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Prospective diagnostic accuracy study
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| Lymph nodes |
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| Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | 19-Gauge Needle | All lymph nodes included in the final analysis were sampled with the 19-gauge and 21-gauge needles. Results will be reported per intervention. |
| OG001 | 21-Gauge Needle | All lymph nodes included in the final analysis were sampled with the 19-gauge and 21-gauge needles. Results will be reported per intervention. |
|
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| 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). | Posted | Count of Units | lymph nodes | 6 months | lymph nodes | lymph nodes |
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| 0 |
| 30 |
| 1 |
| 30 |
| 3 |
| 30 |
| EG001 | 21-Gauge Needle Used First | Patients in this arm had their lymph nodes sampled with the 21-gauge needle first, followed by the 19-gauge needle. All patients were sampled by both needles; randomization and group arm assignment controlled for the order in which the needles were used. | 1 | 30 | 2 | 30 | 4 | 30 |
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| acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient experienced a bronchospasm as a result of bronchoscopy, resulting in acute hypoxic respiratory failure that was treated with nebulizers and BiPAP. |
|
| Missing 19-guage needle spring | Injury, poisoning and procedural complications | Non-systematic Assessment | During EBUS procedure it was noted that there was the lost of 19 gauge needle spring. This was categorized as not severe, as the spring has not been noted in the patient x-rays or during evaluation of the patient. |
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| Blood clot | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | small airway clots noted following bronchoscopy procedure, noted to be mild. |
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| Hypotension | Injury, poisoning and procedural complications | Non-systematic Assessment | Patient experienced hypotension as a result of sedation used for procedure; resolved with nalaxone. |
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| Nausea/Vertigo | Gastrointestinal disorders | Non-systematic Assessment | patient has history of nausea and vertigo; experienced symptoms after the procedure under investigation was completed. |
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| Bleeding | Injury, poisoning and procedural complications | Non-systematic Assessment | patient Experienced minor bleeding at the site and time of procedure. |
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| poor ventilation | Injury, poisoning and procedural complications | Non-systematic Assessment | Patient experienced violent coughing during first attempt at bronchoscopy. Additional sedation was given to prevent coughing, but the patient experienced poor ventilation and a "jaw thrust" was implemented for10 seconds during the procedure. |
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