Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

single arm trial, patients with enlarged mediastinal nodes will be examine

Transbronchial needle forceps will be use with the EBUS TBNA scope

EBUS TBNF

Felix JF Herth, PhD, MD

Ralf Eberhardt, MD

Hendrik Dienemann, PhD, MD

Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes

Patients with enlarged mediastinal lymph nodes must be staged. The EBUS TBNA technique is an established technique. Unfortunately the size of the needle is limited to 21 gauge. With tne new designed needle forceps it should be possible to obtain more material and establish the diagnosis more often

Transbronchial Needle Forceps for Endobronchial Ultrasound

Transbronchial Needle Forceps for EBUS

Heidelberg University

Prof. Felix JF Herth

Blood and Lymph Conditions

Lymphadenopathy

Lymphatic Diseases

EBUS-TBNA is a procedure that allows accurate sampling of mediastinal lymph nodes and peribronchial lesions

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.

Endobronchial Ultrasound

Michel Chalhoub, MD

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

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%.

Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction

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

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

adequate cytological material as a measure of effective diagnostic technique.

Northwell Health

Principal Investigator

Infections

Immune System Diseases

Symptoms and General Pathology

Tuberculosis

Sarcoidosis

Communicable Diseases

Mycobacterium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Lymphoproliferative Disorders

Hypersensitivity

Hypersensitivity, Delayed

ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.

Rapid on-site cytopathologic evaluation (ROSE)

TBNA

Marco Patelli, MD

The purpose of this study is to determine whether rapid on-site cytopathologic evaluation (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the diagnosis of hilar and mediastinal lymphadenopathy.

Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy

Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.

Maggiore Bellaria Hospital, Bologna

Marco Patelli

Multiple Pulmonary Nodules

TBNA + transbronchial lung biopsy + bronchial washing

The main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate.

In a recent systematic literature review (Rivera PM, Mehta AC; Chest 2007; 132: 1318-1488) TBNA showed the highest sensitivity in the diagnostic bronchoscopic approach to peripheral pulmonary lesions, as compared to the other available sampling techniques (transbronchial biopsy, brushing, washings). However, the Authors conclude that the data regarding TBNA in this setting deserve cautious interpretation because of the limited number of studies and the large differences in sample size). We designed the present study to assess the performance characteristics of TBNA, alone and in comparison with those of transbronchial biopsy, in the diagnosis of peripheral pulmonary lesions.

Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy

Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy: Yield and Predictors of a Positive Aspirate

Under fluoroscopy first transbronchial forceps biopsy is performed, afterwards in random order transbronchial catheter aspiration(TBCA) and transbronchial needle aspiration (TBNA).

One arm, in random order first transbronchial catheter aspiration and second transbronchial needle aspiration or vice verse, both techniques routinely used in the diagnosis of peripheral pulmonary lesions; the cytological specimens of TBCA and TBNA are in random order examined by two independent cytologists, all cytological specimens are afterwards examined by a third, supervising cytologist.

TBCA, TBNA

Karl-Josef Franke, MD

The aim of this study is prospectively to determine the diagnostic sensitivity of Transbronchial Catheter Aspiration (TBCA) in comparison with Transbronchial Needle Aspiration (TBNA) in the diagnosis of peripheral nodules and masses of the lung.

The yield of transbronchial forceps biopsy under fluoroscopy in the diagnosis of peripheral lesion of the lung lies between 32 and 57%. Several studies prove an amelioration of success rates by addition of cytological methods such as TBNA, TBCA and bronchial brushing. Furthermore, for TBNA and TBCA a significantly higher yield was reported in comparison with transbronchial forceps biopsy. TBNA and TBCA are routinely used methods, both techniques are safe, the instruments used are certificated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transbronchial Needle Forceps for Endobronchial Ultrasound	NCT01145924	Lung Cancer Lymph Nodes	EBUS TBNF	18 Years - 80 Years	Heidelberg University
Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction	NCT01734980	Mediastinal Lym... Lung Malignanci...	Endobronchial U...	18 Years -	Northwell Health
Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction	NCT01734980	Mediastinal Lym... Lung Malignanci...	Endobronchial U...	18 Years -	Northwell Health
Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy	NCT00915330	Lung Cancer Sarcoidosis Tuberculosis	Rapid on-site c... TBNA	18 Years - 90 Years	Maggiore Bellaria Hospital, Bologna
Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy	NCT00917137	Pulmonary Nodul... Pulmonary Mass	TBNA + transbro...	18 Years - 76 Years	Maggiore Bellaria Hospital, Bologna
Transbronchial Catheter Aspiration and Transbronchial Needle Aspiration in the Diagnosis of Lung Cancer	NCT00807391	Lung Cancer	TBCA, TBNA	18 Years -	Helios Klinik Ambrock

Spots Global Cancer Trial Database for transbronchial needle aspiration