Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction

Mediastinal Lymphadenopathy Clinical Trial

Official title:

Comparison Of Cytologic Accuracy Of Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734980
• Other study ID #: 11-018
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: November 25, 2012
• Start date: February 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2012
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Cytological diagnostic accuracy between endobronchial ultrasonography endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) samples using suction versus samples when no suction is applied.

Description:

Endobronchial ultrasound-guided transbronchial needle aspiration which is known as the EBUS procedure is a low risk procedure performed using bronchoscopy to sample chest lesions. A needle is passed through the bronchoscope to biopsy the chest lesion. Every lesion is usually biopsied 3 to 7 times. In most cases the investigators apply a syringe with negative pressure to the needle inserted into lesion for biopsy. In some cases the investigators don't apply any negative pressure. There are no studies to evaluate which one is better, applying syringe suction or no suction.

In our study, the investigators are planning to do biopsies with or without suction. Then, the pathology samples will be evaluated for any cytologic difference in making the diagnosis. Any patient undergoing the EBUS procedure for chest biopsies will be eligible. Every lesion will be biopsied at least twice with needle with and without suction. The biopsy samples will be then divided into group A where the investigators applied syringe suction and group B where no syringe suction was applied. There is no risk to the patient in addition to the risk of the EBUS procedure itself. The investigators are not performing any additional intervention from the usual standard of care for any patient presenting for the EBUS procedure. Essentially the investigators are simply grouping the suction and no suction pathology samples as A and B for pathologic comparison.

RESULTS: Among the 26 participants, one of the patients (3.8%) had no adequate tissue using both methods; one patient (3.8%) had adequate tissue using suction but no adequate tissue using no suction; and 24 patients had adequate tissue using both methods (92.3%, p= 1.00). Among the twenty-four patients with adequate tissue using both methods, 14 patients (58.3%) had benign pathology using both methods, while ten patients (41.7%) had malignant pathology using both methods (p= 1.00). Considering suction to be the golden method, the sensitivity and specificity of no suction were 100%. Among the 32 sites that were sampled, one site (3.1%) had no adequate tissue using both methods; one site (3.1%) had adequate tissue using suction but no adequate tissue using no suction; and 30 sites had adequate tissue using both methods (93.8%, p= 1.00). Among the thirty sites with adequate tissue using both methods, 17 (56.7%) had benign pathology using both methods; 12 (40.0%) had malignant pathology using both methods; and one site (3.3%) had malignant pathology using suction, but benign pathology using no suction (p= 1.00). Considering suction to be the golden method, the no suction had a sensitivity= 92.3% and specificity= 100%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult subjects who are scheduled to undergo endobronchial ultrasound transbronchial aspiration to sample mediastinal masses or lymph nodes.

Exclusion Criteria:

• Patients who are not able to complete the EBUS procedure for any reason

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Malignancies
• Mediastinal Lymphadenopathy

Intervention

Procedure:
• Endobronchial Ultrasound
The samples will be divided as 2 groups for comparison. Group A is the group of samples where we apply negative pressure syringe for needle suction. Group B is where no suction will be applied after needle insertion.

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	The number of patients with cytological diagnosis as a measure of effective diagnostic technique.	3 days	No
Secondary	Samples adequacy	adequate cytological material as a measure of effective diagnostic technique.	3 days	No