Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michel Chalhoub, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01734980
First received: July 4, 2012
Last updated: November 25, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Mediastinal Lymphadenopathy
Lung Malignancies
Procedure: Endobronchial Ultrasound

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison Of Cytologic Accuracy Of Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Diagnostic yield [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    The number of patients with cytological diagnosis as a measure of effective diagnostic technique.


Secondary Outcome Measures:
  • Samples adequacy [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    adequate cytological material as a measure of effective diagnostic technique.


Enrollment: 30
Study Start Date: February 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endobronchial Ultrasound
EBUS-TBNA is a procedure that allows accurate sampling of mediastinal lymph nodes and peribronchial lesions
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.

Detailed 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%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734980

Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Michel Chalhoub, MD Staten Island University Hospital
  More Information

No publications provided

Responsible Party: Michel Chalhoub, Principal Investigator, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01734980     History of Changes
Other Study ID Numbers: 11-018
Study First Received: July 4, 2012
Last Updated: November 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Endobronchial Ultrasound
transbronchial needle aspiration

ClinicalTrials.gov processed this record on September 18, 2014