Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients enrolled in this single arm study will have lung nodules biopsied by traditional forceps followed by transbronchial cryobiopsy

transbronchial biopsy

David M DiBardino, MD

Purpose: Patients with peripheral lung nodules require evaluation for lung cancer. Our aim is to assess the diagnostic yield of a new technique, transbronchial cryobiopsies, in patients at risk for lung cancer. Target population: Patients referred for bronchoscopy and lung biopsies as a part of their work up for peripheral lung lesions. Procedures: Patients enrolled will have forceps transbronchial biopsies followed by transbronchial cryobiopsies for their lung lesion during bronchoscopy.

Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions

An Un-blinded, Intra-patient Comparison of Transbronchial Forceps Biopsy and Cryobiopsy for Peripheral Pulmonary Lesions

Sensitivity for cancer is defined as true positives / (true positives + false negatives) with respect to diagnosing malignancy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of any further, more invasive testing that is clinically indicated to evaluate the nodule.

Sensitivity is defined as true positives / (true positives + false negatives) with respect to diagnosing a specific benign condition that is thought to represent the lung nodule seen on CT scan. If the bronchoscopic procedure fails to diagnose a specific benign condition, the gold standard will be the results of any further, more invasive testing and stable follow-up imaging at 1 year.

A chest X-ray and ultrasound will be done to check for pneumothorax after standard forceps biopsy and after the addition of transbronchial cryobiopsy. Bleeding will be measured with a standardized scale (grade 0 = traces of blood not requiring suctioning; grade 1 = bleeding requiring suction to clear; grade 2 = bleeding requiring wedging of the biopsied segment with the flexible bronchoscope and/or iced saline/epinephrine; grade 3 = bleeding requiring further intervention such as balloon occlusion or inflation of the bronchial blocker; grade 4 = bleeding resulting in airway obstruction and acute hypoxemic respiratory failure, cardiopulmonary instability, transfusion of packed RBCs, and/or admission to the ICU) both after forceps biopsy and again after transbronchial cryobiopsy.

Andrew Haas

Anil Vachani

Anthony Lanfranco

Kevin Ma

Jeffrey Thompson

Edmund Moon

University of Pennsylvania

Assistant Professor of Clinical Medicine, Section of Interventional Pulmonology and Thoracic Oncology, Assistant Professor of Medicine at the Hospital of the University of Pennsylvania

Endobronchial ultrasound miniprobe is used to identify solid mass in lung parenchyma.

Endobronchial ultrasound miniprobe

Jon A Hardie, MD/PhD

Bronchoscopy of non visible lesions in the lung, have a low diagnostic yield. The use of endoscopic ultrasound might increase the diagnostic yield. This prospective study randomises between bronchoscopy with the use of a ultrasound miniprobe and bronchoscopy without the use of a miniprobe in clinical practice at Haukeland University Hospital.

The study hypothesis:

The use of the ultrasound miniprobe will increase the diagnostic yield of bronchoscopy in non visible lesions.

Bronchoscopy is usually the primary investigation of lesions in the lung. X-ray fluorescence guides the sampling with brushing, biopsy or trans bronchial needle aspiration (TBNA) if the lesion not is visible. Ct guided trans-thoracic sampling will be performed if a the sample is non representative. This will delay the diagnosis, and trans-thoracic sampling has a higher risk of pneumothorax. The use of a ultrasound miniprobe might increase the diagnostic yield of bronchoscopy in non visible lesions. The ultrasound probe in a guide sheath is advanced to the lesion with use of X-ray fluorescence. When the lesion is visualised the miniprobe is removed and sampling is performed with TBNA, biopsy and brushing through the guide sheath. If rapid on site cytoevaluation is negative, new TBNA is performed. Previous trials have shown a diagnostic yield without ultrasound between 40-50% and with ultrasound between 60-80%. The studies with ultrasound have been performed by "super specialists". This study will evaluate bronchoscopy with the use of ultrasound miniprobe in clinical practice without "super specialists". It is a prospective randomised trial.

Utility of Endobronchial Ultrasound in the Investigation of Suspected Lung Cancer.

Diagnostic Utility of Endobronchial Ultrasound in the Investigation of Suspected Malignant Lung Lesions Where the Lesions Are Not Visible During Bronchoscopy.

Helse Sunnmore, 6026 Ålesund

Haukeland University Hospital

Jon Andrew Hardie, MD/PhD

The EBUS probe and GS are confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance.

The EBUS probe and GS are confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained under fluoroscopic guidance.

EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).

EBUS-GS

The radiograph fluoroscopy are performed when the probe and GS are confirmed to reach the lesion by EBUS images ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.

X-ray

Jiayuan Sun, MD

Jiayuan Sun

The purpose of this study is to evaluate the efficacy and safety of endobronchial ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

The investigators evaluated the efficacy and safety of transbronchial biopsy (TBB) and bronchial brushing by endobronchial ultrasonography (EBUS) with a guide sheath (GS) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope center, Shanghai chest Hospital affiliated to Shanghai JiaoTong University School, China. Department of pulmonary medicine, Fukushima Medical University, Japan.Patients are divided into two groups, EBUS-GS-X-ray group and EBUS-GS group.Each subject will be randomized to each group.The study is expected to enroll 100 patients at 2 centers (China:75, Fukushima:25).

EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs

Diagnostic Value of Endobronchial Ultrasound(EBUS) With a Guide Sheath(GS) for Peripheral Pulmonary Lesions(PPLs) Without Fluoroscopy: a Randomized Controlled Trial

The diagnostic value mean sensitivity and specificity in two groups

Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation in two groups

Fukushima Medical University

Shanghai Chest Hospital

Director, Endoscope Center, Shanghai Chest Hospital

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.

Transbronchial Catheter Aspiration and Transbronchial Needle Aspiration in the Diagnosis of Lung Cancer

Transbronchial Catheter Aspiration Compared to Transbronchial Needle Aspiration in the Diagnosis of Peripheral Nodules and Masses of the Lung

Helios Klinik Ambrock

Fluoroscopy are not used in this group. EBUS and GS are inserted into bronchi in the assistance of VBN. The EBUS probe and GS are confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance.

EBUS and GS are inserted into bronchi in the assistance of VBN. The EBUS probe and GS are confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained with fluoroscopic guidance.

VBN is carried out by a VBN software（DirectPath; Olympus, Japan) which can automatically create virtual bronchoscopic images.

Sun Jiayuan, MD

The purpose of this study is to evaluate the feasibility, efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing by using virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) and a Guide Sheath (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

The investigators evaluate the feasibility, efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing by using virtual bronchoscopic navigation (VBN) combined with endobronchial ultrasound (EBUS) and a Guide Sheath (GS) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a three centers prospective randomized controlled trial.The participating centers are Department of endoscopy , Shanghai chest Hospital, Shanghai JiaoTong University, China. Department of endoscopy, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, China. Department of Respiratory Medicine, The First Affiliated Hospital of Guangzhou Medical University, China. Patients are divided into two groups, VBN-EBUS-GS-X-ray group and VBN-EBUS-GS group. Each subject will be randomized to each group. The study is expected to enroll 436 patients at 3 centers.

VBN-EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs

Diagnostic Value of Virtual Bronchoscopic Navigation (VBN) Combined With Endobronchial Ultrasound (EBUS) With a Guide Sheath (GS) for Peripheral Pulmonary Lesions (PPLs) Without Fluoroscopy: a Randomized Controlled Trial

The diagnostic value means sensitivity and specificity in two groups

The operation time includes total operation time,total GS time and total EBUS time

Complications mean a composite of operation-related serious adverse events (pneumothorax, bleeding, etc.) during and after the operation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions	NCT02983903	Solitary Pulmon... Multiple Pulmon...	transbronchial ...	18 Years -	University of Pennsylvania
Utility of Endobronchial Ultrasound in the Investigation of Suspected Lung Cancer.	NCT00398970	Lung Cancer	Endobronchial u...	-	Haukeland University Hospital
EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs	NCT01895166	Lung Cancer	EBUS-GS X-ray	18 Years - 80 Years	Shanghai Chest Hospital
Transbronchial Catheter Aspiration and Transbronchial Needle Aspiration in the Diagnosis of Lung Cancer	NCT00807391	Lung Cancer	TBCA, TBNA	18 Years -	Helios Klinik Ambrock
VBN-EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs	NCT02484066	Lung Cancer	VBN EBUS-GS X-ray	18 Years -	Shanghai Chest Hospital
Utility of Endobronchial Ultrasound in the Investigation of Suspected Lung Cancer.	NCT00398970	Lung Cancer	Endobronchial u...	-	Haukeland University Hospital

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