Trial Outcomes & Findings for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle (NCT NCT03004586)
NCT ID: NCT03004586
Last Updated: 2022-06-22
Results Overview
The primary outcome was the proportion of concordance between the 22-gauge and 25-gauge needles in sample adequacy after two passes. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. Sample adequacy was assessed after 2 passes using each needle in all participants and recorded.
COMPLETED
NA
61 participants
One to two hours.
2022-06-22
Participant Flow
A total of 61 patients were enrolled with a total of 200 lymph node stations evaluated. We randomized the "needle size order" on a per-patient basis with first three needle passes performed with one needle and the remaining 4th and 5th needle passes performed with the other needle. All participants completed the studies and there were no dropouts. Since the randomization was done at the lymph node level, both arms had equal number of participants.
Unit of analysis: Lymph nodes
Participant milestones
| Measure |
Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle
Participants in this group had their lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle.
|
Control Group: First Using a 22-gauge Needle Then 25-gauge Needle
Participants in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle.
|
|---|---|---|
|
Overall Study
STARTED
|
31 200
|
30 200
|
|
Overall Study
COMPLETED
|
31 200
|
30 200
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle
Baseline characteristics by cohort
| Measure |
All Study Participants
n=200 Lymph nodes
Participants had their lymph nodes sampled both with 25-gauge needle first followed by the 22-gauge needle and 22-gauge needle first followed by the 25-gauge needle.
|
|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 10.1 • n=61 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=61 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=61 Participants
|
|
Lymph Nodes Station
Lymph Node Station: 11Rs
|
21 lymph nodes
n=61 Participants
|
|
Lymph Nodes Station
Lymph Node Station: 11Ri
|
12 lymph nodes
n=61 Participants
|
|
Lymph Nodes Station
Lymph Node Station: 10R
|
1 lymph nodes
n=61 Participants
|
|
Lymph Nodes Station
Lymph Node Station: 4R
|
39 lymph nodes
n=61 Participants
|
|
Lymph Nodes Station
Lymph Node Station: 2R
|
7 lymph nodes
n=61 Participants
|
|
Lymph Nodes Station
Lymph Node Station: 7
|
53 lymph nodes
n=61 Participants
|
|
Lymph Nodes Station
Lymph Node Station: 4L
|
27 lymph nodes
n=61 Participants
|
|
Lymph Nodes Station
Lymph Node Station: 10L
|
3 lymph nodes
n=61 Participants
|
|
Lymph Nodes Station
Lymph Node Station: 11L
|
35 lymph nodes
n=61 Participants
|
|
Lymph Nodes Station
Lymph Node Station: 1
|
1 lymph nodes
n=61 Participants
|
|
Lymph Nodes Station
Lymph Node Station: Mass (central)
|
1 lymph nodes
n=61 Participants
|
|
CT Scan Nodal Diameter Short Axis (mm)
|
9.1 millimeters
STANDARD_DEVIATION 5.1 • n=61 Participants
|
|
EBUS Nodal Diameter Short Axis (mm)
|
9.5 millimeters
STANDARD_DEVIATION 4.7 • n=61 Participants
|
|
Lymph Node Characteristic
Lymph Node Characteristic: Normal
|
94 lymph nodes
STANDARD_DEVIATION 47.0 • n=61 Participants
|
|
Lymph Node Characteristic
Lymph Node Characteristic: Tumor (Cohesive)
|
24 lymph nodes
STANDARD_DEVIATION 12 • n=61 Participants
|
|
Lymph Node Characteristic
Lymph Node Characteristic: Tumor (Dis-cohesive)
|
11 lymph nodes
STANDARD_DEVIATION 5.5 • n=61 Participants
|
|
Lymph Node Characteristic
Lymph Node Characteristic: Granulomas/Sclerotic
|
6 lymph nodes
STANDARD_DEVIATION 3.0 • n=61 Participants
|
|
Lymph Node Characteristic
Lymph Node Characteristic: Non-diagnostic
|
10 lymph nodes
STANDARD_DEVIATION 5.0 • n=61 Participants
|
|
Final Diagnosis
Final Diagnosis: Inadequate/Non-diagnostic
|
6 lymph nodes
n=61 Participants
|
|
Final Diagnosis
Final Diagnosis: Normal Lymphoid Tissue
|
128 lymph nodes
n=61 Participants
|
|
Final Diagnosis
Final Diagnosis: Granulomatous Inflammation
|
31 lymph nodes
n=61 Participants
|
|
Final Diagnosis
Final Diagnosis: Necrosis
|
1 lymph nodes
n=61 Participants
|
|
Final Diagnosis
Final Diagnosis: Malignancy
|
34 lymph nodes
n=61 Participants
|
PRIMARY outcome
Timeframe: One to two hours.Population: All participants underwent sampling with both needles.
The primary outcome was the proportion of concordance between the 22-gauge and 25-gauge needles in sample adequacy after two passes. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. Sample adequacy was assessed after 2 passes using each needle in all participants and recorded.
Outcome measures
| Measure |
Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle
n=200 Lymph Nodes
Participants in this group had their lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle.
|
Control Group: First Using a 22-gauge Needle Then 25-gauge Needle
n=200 Lymph Nodes
Participants in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle.
|
|---|---|---|
|
Percentage of Lymph Nodes With Adequate Samples
|
79 Percentage of Lymph Nodes
|
78.5 Percentage of Lymph Nodes
|
SECONDARY outcome
Timeframe: One to two hoursPopulation: All participants underwent sampling with both needles.
The difference in the diagnostic yield between the 22-gauge and 25-gauge needles in terms of degree of concordance with the final diagnosis. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The percentage of concordance was calculated by comparing the 2 passes from each needle to the final diagnosis.
Outcome measures
| Measure |
Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle
n=200 Lymph Nodes
Participants in this group had their lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle.
|
Control Group: First Using a 22-gauge Needle Then 25-gauge Needle
n=200 Lymph Nodes
Participants in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle.
|
|---|---|---|
|
Concordance With the Final Diagnosis
|
82 Percentage of concordance
|
80.5 Percentage of concordance
|
SECONDARY outcome
Timeframe: 1-2 hours (Intra procedurally)Population: Participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person.
The difference in usability between the 22-gauge and 25-gauge needles. All participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person. Measured by a Likert scale 1-5 with 1 being the lowest and 5 being the maximum score. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The participants are reported per intervention.
Outcome measures
| Measure |
Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle
n=122 Needles
Participants in this group had their lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle.
|
Control Group: First Using a 22-gauge Needle Then 25-gauge Needle
n=122 Needles
Participants in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle.
|
|---|---|---|
|
Usability of the Needle
Ease of needle insertion
|
4.27 units on a scale
Standard Deviation 0.85
|
4.95 units on a scale
Standard Deviation 0.20
|
|
Usability of the Needle
Visibility of the sheath
|
4.58 units on a scale
Standard Deviation 0.65
|
4.00 units on a scale
Standard Deviation 0.81
|
|
Usability of the Needle
Scope flexibility
|
4.40 units on a scale
Standard Deviation 0.87
|
4.65 units on a scale
Standard Deviation 0.64
|
|
Usability of the Needle
Ultrasound image quality
|
4.62 units on a scale
Standard Deviation 0.70
|
4.65 units on a scale
Standard Deviation 0.65
|
|
Usability of the Needle
Ease of needle puncture
|
4.57 units on a scale
Standard Deviation 0.75
|
4.53 units on a scale
Standard Deviation 0.60
|
|
Usability of the Needle
Ultrasound image quality following needle insertion
|
4.62 units on a scale
Standard Deviation 0.70
|
4.65 units on a scale
Standard Deviation 0.65
|
|
Usability of the Needle
Ease of needle removal
|
4.71 units on a scale
Standard Deviation 0.54
|
4.99 units on a scale
Standard Deviation 0.11
|
Adverse Events
Intervention Group: First Using a 25-gauge Needle Then 22 Gauge-needle
Control Group: First Using a 22-gauge Needle Then 25 -Gauge Needle
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
George Eapen,MD/ Professor, Pulmonary Medicine
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place