Trial Outcomes & Findings for Evaluation of 19-gauge vs 21-gauge EBUS TBNA in Assessing Thoracic Lymphadenopathy (NCT NCT03657849)

NCT ID: NCT03657849

Last Updated: 2023-03-21

Results Overview

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%

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2023-03-21

Participant Flow

60 consecutive patients referred for EBUS-TBNA sampling between July 2018 and January 2019 were enrolled after providing written consent.

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).

Unit of analysis: Lymph nodes

Participant milestones

Measure	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
Overall Study STARTED	60 144
Overall Study COMPLETED	60 141
Overall Study NOT COMPLETED	0 3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of 19-gauge vs 21-gauge EBUS TBNA in Assessing Thoracic Lymphadenopathy

Baseline characteristics by cohort

Measure	Sampling With 19-gauge and 21-gauge n=141 Lymph nodes 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
Age, Customized Age Distribution · Patients < 18	0 Participants n=60 Participants
Age, Customized Age Distribution · Patients >/= 18	60 Participants n=60 Participants
Sex: Female, Male Female	30 Participants n=60 Participants
Sex: Female, Male Male	30 Participants n=60 Participants
Region of Enrollment United States	60 Participants n=60 Participants

PRIMARY outcome

Timeframe: 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).

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%

Outcome measures

Measure	19-Gauge Needle n=141 lymph nodes All lymph nodes included in the final analysis were sampled with the 19-gauge and 21-gauge needles. Results will be reported per intervention.	21-Gauge Needle n=141 lymph nodes All lymph nodes included in the final analysis were sampled with the 19-gauge and 21-gauge needles. Results will be reported per intervention.
Diagnostic Yield True Positives	69 lymph nodes	68 lymph nodes
Diagnostic Yield True Negatives	57 lymph nodes	57 lymph nodes
Diagnostic Yield False Negatives + False Positives (Not included in calculation of diagnostic yield)	15 lymph nodes	16 lymph nodes

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	19-Gauge Needle n=141 lymph nodes All lymph nodes included in the final analysis were sampled with the 19-gauge and 21-gauge needles. Results will be reported per intervention.	21-Gauge Needle n=141 lymph nodes All lymph nodes included in the final analysis were sampled with the 19-gauge and 21-gauge needles. Results will be reported per intervention.
Diagnostic Yield	126 lymph nodes	125 lymph nodes

Adverse Events

19-Gauge Needle Used First

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

21-Gauge Needle Used First

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	19-Gauge Needle Used First n=30 participants at risk 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.	21-Gauge Needle Used First n=30 participants at risk 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.
Respiratory, thoracic and mediastinal disorders respiratory failure	0.00% 0/30 • 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.	3.3% 1/30 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders acute hypoxic respiratory failure	3.3% 1/30 • Number of events 1 • 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.	0.00% 0/30 • 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.
Injury, poisoning and procedural complications Missing 19-guage needle spring	0.00% 0/30 • 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.	3.3% 1/30 • Number of events 1 • 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.

Other adverse events

Measure	19-Gauge Needle Used First n=30 participants at risk 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.	21-Gauge Needle Used First n=30 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.3% 1/30 • Number of events 1 • 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.	6.7% 2/30 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Blood clot	0.00% 0/30 • 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.	3.3% 1/30 • 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.
Injury, poisoning and procedural complications Hypotension	0.00% 0/30 • 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.	3.3% 1/30 • Number of events 1 • 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.
Gastrointestinal disorders Nausea/Vertigo	0.00% 0/30 • 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.	3.3% 1/30 • Number of events 1 • 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.
Injury, poisoning and procedural complications Bleeding	3.3% 1/30 • Number of events 1 • 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.	0.00% 0/30 • 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.
Injury, poisoning and procedural complications poor ventilation	3.3% 1/30 • Number of events 1 • 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.	0.00% 0/30 • 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.

Additional Information

Meghan O'Brien / Study Coordinator

Regions Hospital

Phone: 612-437-1141

Email: meghan.e.obrien@healthpartners.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place