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

Primary Purpose

Enlarged Lymph Nodes (Excluding Infective)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EBUS TBNA
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Enlarged Lymph Nodes (Excluding Infective)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or older
  • Able to provide informed consent
  • Referred for EBUS TBNA sampling at Regions Hospital

Exclusion Criteria:

  • On therapeutic warfarin, Plavix, or ticagrelor in the past 5 days
  • INR>1.8 or platelets <50K

Sites / Locations

  • Regions Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sampling with 19-gauge and 21-gauge

Arm Description

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.

Outcomes

Primary Outcome Measures

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%
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).

Secondary Outcome Measures

Full Information

First Posted
July 31, 2018
Last Updated
February 22, 2023
Sponsor
HealthPartners Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03657849
Brief Title
Evaluation of 19-gauge vs 21-gauge EBUS TBNA in Assessing Thoracic Lymphadenopathy
Official Title
Evaluation of 19-gauge vs 21-gauge EBUS TBNA in Assessing Thoracic Lymphadenopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
January 25, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares the yield of 19-gauge needles vs 21-gauge needles during EBUS TBNA procedures.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enlarged Lymph Nodes (Excluding Infective)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective diagnostic accuracy study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sampling with 19-gauge and 21-gauge
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EBUS TBNA
Intervention Description
All patients undergo EBUS TBNA with two needle sizes
Primary Outcome Measure Information:
Title
Diagnostic Yield
Description
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%
Time Frame
6 months
Title
Diagnostic Yield
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Able to provide informed consent Referred for EBUS TBNA sampling at Regions Hospital Exclusion Criteria: On therapeutic warfarin, Plavix, or ticagrelor in the past 5 days INR>1.8 or platelets <50K
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Firas S Elmufdi, MBBS
Organizational Affiliation
Regions Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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