search
Back to results

Stylet vs No Stylet During EBUS TBNA

Primary Purpose

Interstitial Lung Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EBUS without stylet
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Interstitial Lung Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients >18 years old and capable of informed consent refereed for EBUS-TBNA at our institution.

Exclusion Criteria:

  • Standard contraindications to EBUS (coagulopathy, anti-platlet/anti-coagulant use, clinical instability)
  • Pregnant women

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EBUS patients

Arm Description

All patients in our study are in the same arm, as each patient serves as their own internal control. More specifically, each enrolled patient will receive both traditional EBUS (with the usage of stylet) and experimental EBUS (EBUS without a stylet) at each lymph node that is included in the experimental analysis.

Outcomes

Primary Outcome Measures

Diagnostic agreement (percentage of samples that have the same diagnosis)
The main outcome is the agreement (concordance) between the pathological diagnosis obtained by preforming EBUS with a stylet with EBUS without a stylet. Each patient will receive both techniques on each lymph node. We will then compare the diagnostic reached by each technique, and calculate the percentage of the time these techniques result in the same diagnosis.

Secondary Outcome Measures

Pneumothorax rate (percentage of procedures that result in a pneumothorax)
Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital
Bleeding rate (% of procedures that have significant bleeding)
Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital
Hospital Admission (% of procedures that result in unanticipated admission to the hospital)
Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital

Full Information

First Posted
June 5, 2014
Last Updated
December 14, 2016
Sponsor
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT02201654
Brief Title
Stylet vs No Stylet During EBUS TBNA
Official Title
Stylet Versus no Stylet in Endobronchial Ultrasound Transbronchial Aspiration (EBUS-TBNA)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

5. Study Description

Brief Summary
This research study compares two ways to biopsy lymph nodes in the chest using endobronchial ultrasound-guided transbronchial needle aspiration" (EBUS-TNBA). During a EBUS-TBNA procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted through the mouth into the large airways of the chest, allowing us to see (via ultrasound) and biopsy the lymph nodes in the chest. The purpose of this research study is to determine if the EBUS-TBNA procedure can be made simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an inner stylet that runs through the middle of the needle. Because many other biopsy needles (such as the needles used in breast biopsy and different types of lung biopsy needles) do not use an inner stylet, the investigators do not think the use of a stylet is necessary. If this step can be safely eliminated without decreasing the effectiveness of the procedure, this could shorten the procedure (saving time). This study is deigned to formally test the hypothesis that a stylet is not necessary in EBUS-TBNA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBUS patients
Arm Type
Other
Arm Description
All patients in our study are in the same arm, as each patient serves as their own internal control. More specifically, each enrolled patient will receive both traditional EBUS (with the usage of stylet) and experimental EBUS (EBUS without a stylet) at each lymph node that is included in the experimental analysis.
Intervention Type
Other
Intervention Name(s)
EBUS without stylet
Intervention Description
the patient will receive both conventional ebus with the stylet and experimental ebus (without the stylet). The two techniques will then be compared to each other on a per lymph node basis.
Primary Outcome Measure Information:
Title
Diagnostic agreement (percentage of samples that have the same diagnosis)
Description
The main outcome is the agreement (concordance) between the pathological diagnosis obtained by preforming EBUS with a stylet with EBUS without a stylet. Each patient will receive both techniques on each lymph node. We will then compare the diagnostic reached by each technique, and calculate the percentage of the time these techniques result in the same diagnosis.
Time Frame
At time of biopsy
Secondary Outcome Measure Information:
Title
Pneumothorax rate (percentage of procedures that result in a pneumothorax)
Description
Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital
Time Frame
1 week post-procedure
Title
Bleeding rate (% of procedures that have significant bleeding)
Description
Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital
Time Frame
1 week post-procedure
Title
Hospital Admission (% of procedures that result in unanticipated admission to the hospital)
Description
Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital
Time Frame
1 week post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients >18 years old and capable of informed consent refereed for EBUS-TBNA at our institution. Exclusion Criteria: Standard contraindications to EBUS (coagulopathy, anti-platlet/anti-coagulant use, clinical instability) Pregnant women
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Stylet vs No Stylet During EBUS TBNA

We'll reach out to this number within 24 hrs