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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00624 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle | Experimental | Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle. |
|
| EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle | Experimental | Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25-Gauge Needle | Device | Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One to two hours. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George A. Eapen, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group: First Using a 22-gauge Needle Then 25-gauge Needle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Sep 20, 2016 |
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| 22-Gauge Needle | Device | Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle. |
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| Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) | Procedure | Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed. |
|
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| One to two hours |
| 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. | 1-2 hours (Intra procedurally) |
Participants in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Lymph nodes |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | 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 | Number | participants | Participants |
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| Lymph Nodes Station | Number | lymph nodes | Participants |
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| CT Scan Nodal Diameter Short Axis (mm) | Mean | Standard Deviation | millimeters | Participants |
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| EBUS Nodal Diameter Short Axis (mm) | Mean | Standard Deviation | millimeters | Participants |
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| Lymph Node Characteristic | Mean | Standard Deviation | lymph nodes | Participants |
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| Final Diagnosis | Number | lymph nodes | Participants |
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| 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 | 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. | All participants underwent sampling with both needles. | Posted | Number | Percentage of Lymph Nodes | One to two hours. | Lymph Nodes | Lymph Nodes |
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| 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. | All participants underwent sampling with both needles. | Posted | Number | Percentage of concordance | One to two hours | Lymph Nodes | Lymph Nodes |
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| 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. | Participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person. | Posted | Mean | Standard Deviation | units on a scale | 1-2 hours (Intra procedurally) | Needles | Needles |
|
within 24 hours of procedure
adverse events were monitored for irrespective of specific needle intervention and therefore cannot be reported separately
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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 | Intervention Group: First Using a 25-gauge Needle Then 22 Gauge-needle | Participants lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle and sampled with 22-gauge needle first followed by the 25-gauge needle. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG001 | Control Group: First Using a 22-gauge Needle Then 25 -Gauge Needle | Patients in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Eapen,MD/ Professor, Pulmonary Medicine | UT MD Anderson Cancer Center | (713) 563-4256 | geapen@mdanderson.org |
| Jun 21, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Title | Measurements |
|---|---|
| Female |
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| Male |
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| Title | Measurements |
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| Title | Measurements |
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| Lymph Node Station: 11Ri |
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| Lymph Node Station: 10R |
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| Lymph Node Station: 4R |
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| Lymph Node Station: 2R |
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| Lymph Node Station: 7 |
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| Lymph Node Station: 4L |
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| Lymph Node Station: 10L |
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| Lymph Node Station: 11L |
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| Lymph Node Station: 1 |
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| Lymph Node Station: Mass (central) |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Title | Measurements |
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| Lymph Node Characteristic: Tumor (Cohesive) |
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| Lymph Node Characteristic: Tumor (Dis-cohesive) |
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| Lymph Node Characteristic: Granulomas/Sclerotic |
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| Lymph Node Characteristic: Non-diagnostic |
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| Title | Measurements |
|---|---|
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| Final Diagnosis: Normal Lymphoid Tissue |
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| Final Diagnosis: Granulomatous Inflammation |
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| Final Diagnosis: Necrosis |
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| Final Diagnosis: Malignancy |
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| Lymph Nodes |
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| Units | Counts |
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| Participants |
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| Needles |
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