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


N/A
18 Years
N/A
Not Enrolling
Both
Mediastinal Lymphadenopathy, Lung Malignancies

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Trial Information

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


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%.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Diagnostic yield

Outcome Description:

The number of patients with cytological diagnosis as a measure of effective diagnostic technique.

Outcome Time Frame:

3 days

Safety Issue:

No

Principal Investigator

Michel Chalhoub, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Staten Island University Hospital

Authority:

United States: Institutional Review Board

Study ID:

11-018

NCT ID:

NCT01734980

Start Date:

February 2011

Completion Date:

November 2011

Related Keywords:

  • Mediastinal Lymphadenopathy
  • Lung Malignancies
  • Endobronchial Ultrasound
  • transbronchial needle aspiration
  • Neoplasms
  • Lung Neoplasms
  • Lymphatic Diseases

Name

Location

Staten Island University HospitalStaten Island, New York  10305