Stylet vs No Stylet During EBUS TBNA

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

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Other: EBUS without stylet

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: July 25, 2014
• First Posted (Estimate): July 28, 2014

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: NA_00093452