Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The EBUS probe is confirmed to reach the lesion by EBUS images alone, cytologic and pathologic specimens are obtained without fluoroscopic guidance.

Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The EBUS probe is confirmed to reach the lesion by EBUS images and radiograph fluoroscopy, cytologic and pathologic specimens are obtained under fluoroscopic guidance.

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

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.

EBUS

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

X-ray

Jiayuan Sun, PhD

The purpose of this study is to evaluate the feasibility,efficacy and safety of ultrathin bronchoscopy(UTB) combined with virtual bronchoscopic navigation(VBN) and endobronchial ultrasound(EBUS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

The investigators evaluate feasibility,efficacy and safety of UTB combined with VBN and EBUS for the diagnosis of PPLs without radiographic fluoroscopy.Bronchoscopes with a 3.0-mm distal end diameter and a 1.7-mm working channel diameter are used (BF-Y0058;Olympus).The final diagnoses are established by pathological evidence from biopsy or cytology specimen including bronchoscopy or other procedures,microbiological analysis and clinical follow-up.The study is designed as a single center prospective randomized controlled trial.The participating center is Department of endoscopy, Shanghai Chest Hospital, Shanghai Jiao Tong University, China.Subjects will be randomized (1:1) to UTB-VBN-EBUS-X-ray group and UTB-VBN-EBUS group based on a randomization schedule.The study is expected to enroll 200 patients with 100 patients of each group.

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

Ultrathin Bronchoscopy With Virtual Bronchoscopic Navigation and Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions Without Fluoroscopy: a Randomized Controlled Trial

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

The diagnostic value means diagnostic yields in two groups for benign and malignant lesions

The operation time means the total operation time and the total EBUS time.

Shanghai Chest Hospital

Director, Department of Endoscopy, Shanghai Chest Hospital

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Lidocaine

Anesthetics

patients receive CT-TTNB to diagnose PPLs.

patients receive EBUS-GS to diagnose PPLs.

The equipment for EBUS-GS includes super-thin bronchoscope BF-P260F, endobronchial ultrasonic system EU-M30S, ultrasonic probe UM-S20-17S, and guided sheath kit K201. All facilities are provided by Olympus Co. The EBUS-GS procedure was performed by thoracic surgeons. The patient was in supine position, under general anesthesia, and provided ventilatation through laryngeal mask. First, the operator placed super-thin bronchoscope into the bronchus of interest, inserted the probe covered with GS through a work channel. Later, adjusted the bronchoscope and probe to obtain classical ultrasonic graphs. The assistant fixed the bronchoscope, pulled the probe out, and placed the brush and biopsy forceps, respectively, through the GS. This process was assisted using x-ray fluoroscope or not.

EBUS-GS

The devices for CT-TTNB includes Lightspeed VCT spiral CT(GE co.) and Quickcore(COOK Co.) biopsy kit. The kit includes a sheath(5cm in length and 16G in outer diameter) and a automatic biopsy needle(15cm in length and 18G in outer diameter). The patient stays in supine, prone or lateral position according to the lesion's location. The first chest CT scan is performed to confirm the location of the lesion and make an optimal entry point. Then, after sterilization and 2% lidocaine local anesthesia, the sheath is stabbed into chest wall through the entry point. The second CT scan is performed to make sure that the sheath stays in proper angle and depth. The operator places the needle through the sheath and enter the lesion. Then fire the biopsy needle and repeat the procedure twice or third time. The last CT scan is conducted to determine whether pneumothorax or hemorrhage occurred.

CT-TTNB

Guanchao Jiang, M.D.

Guanchao Jiang, M.D

This is a randomized controlled trail aiming at comparing the diagnostic value and safety of endobronchial ultrasonography with a guide sheath(EBUS-GS) and computed tomography-guided transthoracic needle biopsy(CT-TTNB) for peripheral pulmonary lesions (PPLs). Patients eligible for the inclusion criteria are diagnosed using either EBUS-GS or CT-TTNB randomly. The diagnostic indicators such as sensitivity, specificity, and accuracy are compared between the two groups. Post-procedure complications are recorded.

CT-TTNB is widely used in the diagnosis of PPLs and its sensitivity for lung cancer remains as high as 90%. However, the relatively high rate of complications such as pneumothorax, hemoptysis, pulmonary hemorrhage, severe chest pain, and bad tolerance in patients limits its application.

EBUS-GS is an emerging technology, Kurimoto in 2004 performed transbronchial lung biopsy(TBLB) assisted by EBUS-GS, and the sensitivity of diagnosing lung cancer was 81%, and it was proved to be a safe procedure with very small amount of pneumothorax and hemoptysis.

Till now there is only one randomized controlled study comparing the diagnostic value of CT-TTNB and EBUS-GS; however, it did not complete the enrollment of patients on schedule. In addition, all the other studies were retrospective. Hence this prospective study was performed to determine the diagnostic value and safety of EBUS-GS and CT-TTNB for PPLs.

A Comparison Between EBUS-GS and CT-guided Lung Biopsy in Diagnosis of Peripheral Pulmonary Lesions.

Endobronchial Ultrasonography With a Guide Sheath Versus Computed Tomography-guided Transthoracic Needle Biopsy in the Diagnosis of Peripheral Pulmonary Lesions

Adverse events include: 1)pneumothorax or pulmonary hemorrhage which are observed in CT scan after CT-TTNB; 2)patient's complaint of chest pain or dyspnea after returning the ward, and bedside X-ray shows pneumothorax or decreased respiratory auscultation，and drainage should be performed; 3)postoperative hemoptysis and usage of hemostatic agents;4)severe chest pain, but no pneumothorax in chest film, no T wave or ST segment changes in ECG,and analgesics should be used;5)new tumor or subcutaneous nodules are found in the needle channel during the follow-up;6)other adverse events: such as pleural reaction; arrhythmia, continuous hypoxemia or persistent hypotension during anesthesia process; hoarseness after EBUS-GS,and cricoarytenoid joint dislocation is found by laryngoscope.

If the pathological results from EBUS-GS or CT-TTNB show lung cancer, metastatic carcinoma or other malignant tumors, they are recorded as accurate.

If the patient undergoes the following surgical treatment, the histological results from the resected tissues are "golden standard".

If the pathological diagnosis is non-neoplastic and the patient does not receive surgery, the follow-up radiographic findings will decide. If there is no change or reduction in size, it is considered as accurate, otherwise false negative.

If the biopsy diagnosis are mucosa, cartilage, coagulation, necrosis or other description that can not make a predisposed diagnosis. They are also recorded as negative results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
UTB-VBN-EBUS With or Without Fluoroscopy for the Diagnosis of PPLs	NCT02664259	Lung Cancer	VBN EBUS 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
A Comparison Between EBUS-GS and CT-guided Lung Biopsy in Diagnosis of Peripheral Pulmonary Lesions.	NCT02740400	Lung Neoplasms	EBUS-GS CT-TTNB	-	Peking University People's Hospital
Utility of Endobronchial Ultrasound in the Investigation of Suspected Lung Cancer.	NCT00398970	Lung Cancer	Endobronchial u...	-	Haukeland University Hospital

Spots Global Cancer Trial Database for endobronchial ultrasonography