Clinical Trials Logo

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.


Clinical Trial 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%. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01734980
Study type Interventional
Source Northwell Health
Contact
Status Completed
Phase N/A
Start date February 2011
Completion date November 2011

See also
  Status Clinical Trial Phase
Completed NCT05535439 - Diagnostic Yield & Specimen Adequacy of Flex 19 G vs 22 G EBUS Needle - A Randomized Controlled Trial N/A
Completed NCT04572984 - Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in the Diagnosis of Mediastinal Lesions N/A
Withdrawn NCT01467635 - EBUS-TBNA Versus EBUS-TBNB N/A
Recruiting NCT01367366 - Dx Mediastinal Malignant LAP:Compare PET and EBUS-TBNA N/A
Not yet recruiting NCT02398864 - Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy N/A
Not yet recruiting NCT04200105 - EBUS-TBNA vs Acquire TBNB N/A
Recruiting NCT05374447 - Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy N/A
Not yet recruiting NCT05110950 - Endobronchial Ultrasound Needle Aspiration With and Without Suction N/A
Recruiting NCT01493739 - EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy N/A
Active, not recruiting NCT05077111 - A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia Phase 4
Completed NCT02689050 - Optical Biopsy for Thoracic Lymph Nodes. N/A
Completed NCT02710565 - Use of EBUS TBNA for Cell Culture as an Aid to Diagnose Lung Cancer and Lymphoma N/A
Completed NCT01658280 - Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration for the Diagnosis of Hilar/Mediastinal Lymphadenopathies Phase 4
Recruiting NCT01121432 - Diagnosis of Mediastinal Tuberculous Lymphadenopathy by Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) N/A
Recruiting NCT05803239 - Study on Transbronchial Ultrasound-guided Cryobiopsy in the Diagnosis of Mediastinal Lymphadenopathy N/A
Recruiting NCT06347939 - Mediastinal EBUS Cryobiopsy Study In Sweden
Completed NCT04306614 - Capillary Versus Suction Needle Aspiration for Endobronchial Ultrasound (EBUS) Biopsies. N/A
Terminated NCT03829618 - Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound Phase 3