Lung Cancer, Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma
Conditions
Keywords
Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma, Lung cancer, Ultrasound-guided transbronchial needle aspiration, EBUS-TBNA, 25-gauge needle, 22-gauge needle
Brief summary
The goal of this clinical research study is to compare the effectiveness of a smaller, 25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) instead of a standard 22-gauge needle. The safety of the needles will also be studied.
Detailed description
As a part of participant's standard-of-care, participant will have a bronchoscopy of lesions on participant's lung nodules and/or lymph nodes before the EBUS-TBNA. Participant will sign a separate consent for the bronchoscopy. If participant agrees to take part in this study, before participant's bronchoscopy, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. * If participant is in Group 1, participant will have the EBUS-TBNA performed by first using a 25-gauge needle, followed by a 22-gauge needle. * If participant is in Group 2, participant will have the EBUS-TBNA performed by first using a 22-gauge needle, followed by a 25-gauge needle. To perform an EBUS-TBNA, a needle is inserted into the affected area using ultrasound imaging to collect tissue from the lungs and lymph nodes. The doctor will use the imaging to guide the needle into the area. Length of Study: Participation on the study will be over after the bronchoscopy and EBUS-TBNA. This is an investigational study. The 22-gauge and 25-gauge needles are FDA approved for use in EBUS-TBNAs. The comparison of the 2 needles for this procedure is investigational. The study doctor can explain how the needles are designed to work. Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.
Interventions
DEVICE25-Gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
DEVICE22-Gauge Needle
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.
Sponsors
Boston Scientific Corporation
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. Indication for EBUS-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes.
Exclusion criteria
1. Patients who are pregnant or lactating 2. Inability to give informed consent 3. Patients in which only one lymph node station is expected to be sampled by the performing clinician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Lymph Nodes With Adequate Samples | One to two hours. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance With the Final Diagnosis | One to two hours | 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. |
| Usability of the Needle | 1-2 hours (Intra procedurally) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants 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. | 61 |
| All Study Participants 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. | 200 |
| Total | 261 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 10.1 |
| CT Scan Nodal Diameter Short Axis (mm) | 9.1 millimeters STANDARD_DEVIATION 5.1 |
| EBUS Nodal Diameter Short Axis (mm) | 9.5 millimeters STANDARD_DEVIATION 4.7 |
| Final Diagnosis Final Diagnosis: Granulomatous Inflammation | 31 lymph nodes |
| Final Diagnosis Final Diagnosis: Inadequate/Non-diagnostic | 6 lymph nodes |
| Final Diagnosis Final Diagnosis: Malignancy | 34 lymph nodes |
| Final Diagnosis Final Diagnosis: Necrosis | 1 lymph nodes |
| Final Diagnosis Final Diagnosis: Normal Lymphoid Tissue | 128 lymph nodes |
| Lymph Node Characteristic Lymph Node Characteristic: Granulomas/Sclerotic | 6 lymph nodes STANDARD_DEVIATION 3 |
| Lymph Node Characteristic Lymph Node Characteristic: Non-diagnostic | 10 lymph nodes STANDARD_DEVIATION 5 |
| Lymph Node Characteristic Lymph Node Characteristic: Normal | 94 lymph nodes STANDARD_DEVIATION 47 |
| Lymph Node Characteristic Lymph Node Characteristic: Tumor (Cohesive) | 24 lymph nodes STANDARD_DEVIATION 12 |
| Lymph Node Characteristic Lymph Node Characteristic: Tumor (Dis-cohesive) | 11 lymph nodes STANDARD_DEVIATION 5.5 |
| Lymph Nodes Station Lymph Node Station: 1 | 1 lymph nodes |
| Lymph Nodes Station Lymph Node Station: 10L | 3 lymph nodes |
| Lymph Nodes Station Lymph Node Station: 10R | 1 lymph nodes |
| Lymph Nodes Station Lymph Node Station: 11L | 35 lymph nodes |
| Lymph Nodes Station Lymph Node Station: 11Ri | 12 lymph nodes |
| Lymph Nodes Station Lymph Node Station: 11Rs | 21 lymph nodes |
| Lymph Nodes Station Lymph Node Station: 2R | 7 lymph nodes |
| Lymph Nodes Station Lymph Node Station: 4L | 27 lymph nodes |
| Lymph Nodes Station Lymph Node Station: 4R | 39 lymph nodes |
| Lymph Nodes Station Lymph Node Station: 7 | 53 lymph nodes |
| Lymph Nodes Station Lymph Node Station: Mass (central) | 1 lymph nodes |
| Region of Enrollment United States | 61 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
Primary
Percentage of Lymph Nodes With Adequate Samples
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.
Time frame: One to two hours.
Population: All participants underwent sampling with both needles.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle | Percentage of Lymph Nodes With Adequate Samples | 79 Percentage of Lymph Nodes |
| Control Group: First Using a 22-gauge Needle Then 25-gauge Needle | Percentage of Lymph Nodes With Adequate Samples | 78.5 Percentage of Lymph Nodes |
Secondary
Concordance With the Final Diagnosis
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.
Time frame: One to two hours
Population: All participants underwent sampling with both needles.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle | Concordance With the Final Diagnosis | 82 Percentage of concordance |
| Control Group: First Using a 22-gauge Needle Then 25-gauge Needle | Concordance With the Final Diagnosis | 80.5 Percentage of concordance |
Secondary
Usability of the Needle
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle | Usability of the Needle | Scope flexibility | 4.40 units on a scale | Standard Deviation 0.87 |
| Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle | Usability of the Needle | Ease of needle puncture | 4.57 units on a scale | Standard Deviation 0.75 |
| Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle | Usability of the Needle | Visibility of the sheath | 4.58 units on a scale | Standard Deviation 0.65 |
| Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle | Usability of the Needle | Ultrasound image quality following needle insertion | 4.62 units on a scale | Standard Deviation 0.7 |
| Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle | Usability of the Needle | Ultrasound image quality | 4.62 units on a scale | Standard Deviation 0.7 |
| Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle | Usability of the Needle | Ease of needle removal | 4.71 units on a scale | Standard Deviation 0.54 |
| Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle | Usability of the Needle | Ease of needle insertion | 4.27 units on a scale | Standard Deviation 0.85 |
| Control Group: First Using a 22-gauge Needle Then 25-gauge Needle | Usability of the Needle | Ease of needle removal | 4.99 units on a scale | Standard Deviation 0.11 |
| Control Group: First Using a 22-gauge Needle Then 25-gauge Needle | Usability of the Needle | Ease of needle insertion | 4.95 units on a scale | Standard Deviation 0.2 |
| Control Group: First Using a 22-gauge Needle Then 25-gauge Needle | Usability of the Needle | Visibility of the sheath | 4.00 units on a scale | Standard Deviation 0.81 |
| Control Group: First Using a 22-gauge Needle Then 25-gauge Needle | Usability of the Needle | Scope flexibility | 4.65 units on a scale | Standard Deviation 0.64 |
| Control Group: First Using a 22-gauge Needle Then 25-gauge Needle | Usability of the Needle | Ultrasound image quality | 4.65 units on a scale | Standard Deviation 0.65 |
| Control Group: First Using a 22-gauge Needle Then 25-gauge Needle | Usability of the Needle | Ease of needle puncture | 4.53 units on a scale | Standard Deviation 0.6 |
| Control Group: First Using a 22-gauge Needle Then 25-gauge Needle | Usability of the Needle | Ultrasound image quality following needle insertion | 4.65 units on a scale | Standard Deviation 0.65 |