Stylet vs No Stylet During EBUS TBNA

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201654
• Other study ID #: NA_00093452
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: December 14, 2016
• Start date: June 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At time of biopsy	No
Secondary	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	1 week post-procedure	Yes
Secondary	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	1 week post-procedure	Yes
Secondary	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	1 week post-procedure	Yes