Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique and presence of ROSE

Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no guide sheath and the presence of ROSE.

Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique but without ROSE.

Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no the guide sheath an without the presence of ROSE.

Pathologist on site for direct evaluation of specimen adequacy

Rapid on-site evaluation (ROSE)

peripheral endobronchial ultrasound performed with a slim bronchoscope (3.0 mm outer diameter with a 1.7mm channel) combined with a radial ultrasound probe but without the use of a guide sheath.

Slim bronchoscope without a guide sheath

Using a flexible bronchoscope with minimal outer diameter of 4.2mm.

Standard pEBUS with guide sheath

Alain Tremblay, MDCM

Peripheral pulmonary lesions (PPL) are defined as nodules or masses that are located in the lung periphery; hence cannot be seen via regular bronchoscopy. Due to their location, establishing a pathological diagnosis can be challenging. Investigations of PPL has significantly evolved in the last decade with the development of new technologies such as peripheral endobronchial ultrasound (pEBUS), virtual bronchoscopy and electromagnetic navigational bronchoscopy (ENB). Although these technologies have allowed physicians to safely biopsy previously difficult to access nodules, their sensitivity have been lower than trans-thoracic needle aspiration (TTNA). In fact, the largest registry to date has found a diagnostic yield of pEBUS of 57% compared to 93% for TTNA. However, TTNA caries substantially more procedural risk than pEBUS with a 25% rate of complication vs 2.8% for pEBUS (1, 2). With increased sensitivity, pEBUS could become the procedure of choice for PPL investigation in view of its safety profile. Rapid on-site evaluation of biopsy samples by a cytopathologist (ROSE) allows for direct evaluation of specimen adequacy. By offering real-time feedback to the bronchoscopist about specimen adequacy, the adding of ROSE to pEBUS could lead to an increase in diagnostic yield, allowing for a faster diagnosis of lung cancer and avoiding the need for further diagnostic procedures. Minitiazuration of broncoscopes can also allow navigation to more distal areas of the lung closer to the PPL. While this may also improve diagnostic yield, other technical modification such as the need for smaller sampling instruments and inability to use a guide sheath may have drawbacks.

This study will use a 2 x 2 factorial design to compare diagnostic yield of pEBUS bronchoscopic PPL sampling with vs. without ROSE as well as with a novel "slim" bronchoscope vs. standard bronchoscope. The investigators aim to randomize 208 patients to independently test each hypothesis.

Peripheral EBUS With ROSE vs no ROSE; Slim Bronchoscope Without Guide Sheath vs Standard Bronchoscope With Guide Sheath

Rapid On-site Evaluation and Use of a Slim Bronchoscope During Peripheral Endobronchial Ultrasonography for the Investigation of Peripheral Pulmonary Lesion - A Randomized Controlled Factorial Trial

Individual deidentified participant data that underlie the results reported in this article (text, tables, figures and appendices) will be shared with researchers who provide a methodologically sound proposal. Other accessible documents will include the study protocol. Beginning 9 months and ending 36 months following article publications, proposals may be submitted to alain.tremblay@ucalgary.ca. To gain access, data requestors will need to sign a data access agreement.

Sample adequacy for EGFR mutation analysis, ALK and PDL1 immunohistochemistry.

Combination of endpoints following chart review, including but not limited to unplanned hospitalization or emergency room visit, hemoptysis, pneumothorax, chest infection, fever or exacerbation of lung disease.

McGill University

Laval University

University of Calgary

All Drugs and Chemicals

Dimercaprol

Patients will undergo bronchoscopy and radial endobronchial ultrasound-guided biopsy of a peripheral lung lesion like patients in the other group. However, single-plane fluoroscopy will be used to help locate the lesion (with the help of a steerable curette) in case of failure to locate the lesion, and it will also be used to guide tissue sampling and ensure appropriate sampling tool function. Transbronchial biopsies, transbronchial needle aspiration, brushings, and bronchoalveolar lavage will be performed for each lesion.

Patients will undergo biopsy of peripheral lung lesions using radial endobronchial ultrasound guidance only, without the use of fluoroscopy. Transbronchial biopsies, transbronchial needle aspiration, brushings, and bronchoalveolar lavage will be performed for each lesion.

Fluoroscopy

Radial EBUS-guided biopsy

Antoine Delage, MD

The purpose of this study is to determine whether the use of fluoroscopy improves the diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial ultrasound (with the use of a guide sheath).

Study on the Influence of Fluoroscopy in the Diagnosis of Peripheral Lung Lesions With Endobronchial Ultrasound Guidance

Randomized Trial of Fluoroscopy Use for Radial Endobronchial Ultrasound-guided Biopsy of Peripheral Lung Lesions

Diagnostic yield of radial endobronchial ultrasound-guided biopsy for peripheral lung lesions defined as the proportion of patients in whom a specific diagnosis is established by radial endobronchial ultrasound-guided biopsy. The analysis will be stratified by lesion size, location, the presence of the bronchus sign, type of echographic image obtained (central/peripheral), physician involved, resident involvement.

Sensitivity and specificity are determined separately for malignancy and benign etiologies. Case records will be reviewed for patients with non-diagnostic specimen and results from other diagnostic procedures (TTNA, surgical biopsy) will be reviewed. For patients without further diagnostic tests, stability or progression of the lesion over time will be used for etiology attribution.

Proportion of patients in whom the peripheral pulmonary lesion was localized using the radial endobronchial ultrasound.

Total duration of the bronchoscopic test.

occurrence of pneumothorax (and its management), bleeding more than 50ml, sustained desaturation below 90%, cardiac dysrhythmias, or any other adverse events occuring during or after the procedure.

Patients with peripheral pulmonary lesions which require histological differentiation because of the possibility of malignancy, and a biopsy can be attempted through guided bronchoscopy

It is performed when a pulmonary lesion with a possibility of malignancy is found on chest CT and histological diagnosis and differentiation are required.

Guided bronchoscopy

Yeon Wook Kim, MD., PhD

Sun Hyo Park

So Jeong Kim

Hyung Joo Oh

Hyung Gu Kang

Jong Whan Jeong

Yeon Wook Kim, MD, PhD

Wonjun Ji

Chi Young Kim

Dong Won Park

Hyeong Jun Cho

Seong Hoon Yoon

The primary objective is To evaluate the usefulness and safety of advanced guided bronchoscopy for histological diagnosis of peripheral pulmonary lesions.

The Secondary objective is to establish a strategy that can most effectively use endoscopes for early diagnosis of lung cancer in a real-world care environment by identifying patient/clinical/image/procedure-related characteristics that can optimize the practicality of emerging technologies.

* Patients with peripheral pulmonary lesions who need histological diagnosis due to suspected lung cancer and whose lesions are judged capable of histological examination through guided bronchoscopy will be prospectively recruited.
* This study is a pure non-interventional pragmatic design. In addition to biopsy for lung lesions using bronchoscopy, lung cancer staging and tests necessary for metastases and treatment for diagnosed lung cancer are performed according to existing guidelines and the judgment of medical staff.
* We will analyze the clinical characteristics of guided bronchoscopy procedures used in clinical practice and the main results during the follow-up period of up to one year (diagnostic yield, sensitivity, safety, practicality, and various factors affecting usefulness).

Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

Korean Multicenter Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions

The proportion of pathologic results that leads to a specific malignant or benign

True positive + True negative (confirmed benign with follow-up of at least 1yr without progression) / Total procedures

Pathologic results of a malignant or benign specific diagnosis based on the samples collected via index ENB procedure are categorized as true positives or true negatives.

For pathologic results of a benign non-specific diagnosis and non-diagnostic results, follow-up data would be used to determine whether the 12-month status corroborates the benign results. Based on definition scenarios, these results will be determined as true negatives or false negatives. Diagnostic yields based on different scenarios will be reported.

Evaluate complications due to guided bronchoscopic biopsy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Peripheral EBUS With ROSE vs no ROSE; Slim Bronchoscope Without Guide Sheath vs Standard Bronchoscope With Guide Sheath	NCT03809169	Peripheral Pulm... Lung Cancer	Rapid on-site e... Slim bronchosco... Standard pEBUS ...	18 Years -	University of Calgary
Study on the Influence of Fluoroscopy in the Diagnosis of Peripheral Lung Lesions With Endobronchial Ultrasound Guidance	NCT01863836	Peripheral Pulm...	Fluoroscopy Radial EBUS-gui...	18 Years -	Laval University
Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions	NCT05804786	Lung Cancer	Guided bronchos...	19 Years -	Seoul National University Bundang Hospital
Prospective Cohort of Diagnostic Bronchoscopy for Peripheral Lung Lesions	NCT05804786	Lung Cancer	Guided bronchos...	19 Years -	Seoul National University Bundang Hospital
Study on the Influence of Fluoroscopy in the Diagnosis of Peripheral Lung Lesions With Endobronchial Ultrasound Guidance	NCT01863836	Peripheral Pulm...	Fluoroscopy Radial EBUS-gui...	18 Years -	Laval University

Spots Global Cancer Trial Database for radial endobronchial ultrasound