Stylet vs No Stylet During EBUS TBNA

NCT02201654 | Completed

• 1 other identifier: NA_00093452
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pneumothorax rate (percentage of procedures that result in a pneumothorax)

  1 week post-procedure

• Bleeding rate (% of procedures that have significant bleeding)

  1 week post-procedure

• Hospital Admission (% of procedures that result in unanticipated admission to the hospital)

  1 week post-procedure

Study Arms (1)

EBUS patients

OTHER

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

Interventions

EBUS without stylet OTHER

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.

EBUS patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: July 28, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)