Stylet vs No Stylet During EBUS TBNA

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT02201654

Collaborator

(none)

121

Enrollment

Location

Arm

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease	Other: EBUS without stylet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

121 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Stylet Versus no Stylet in Endobronchial Ultrasound Transbronchial Aspiration (EBUS-TBNA)

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: EBUS patients 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.	Other: EBUS without stylet 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.

Arm

Intervention/Treatment

Other: EBUS patients

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.

Other: EBUS without stylet

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.

Outcome Measures

Primary Outcome Measures

Diagnostic agreement (percentage of samples that have the same diagnosis) [At time of biopsy]
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) [1 week post-procedure]
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) [1 week post-procedure]
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) [1 week post-procedure]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21218

Sponsors and Collaborators

Johns Hopkins University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT02201654

Other Study ID Numbers:

NA_00093452

First Posted:

Jul 28, 2014

Last Update Posted:

Dec 15, 2016

Last Verified:

Dec 1, 2016

Additional relevant MeSH terms:

Lung Diseases

Lung Diseases, Interstitial

Study Results

No Results Posted as of Dec 15, 2016