Evaluate the Diagnostic Value of BTPNA for PPL: a Real-world Study

Study Overview
=================
Brief Summary
-----------------
The study is designed as a multicenter prospective trial of BTPNA for the diagnosis of peripheral pulmonary lesions in the real world. The purpose of the study is to evaluate the safety and effectiveness of BTPNA and to explore the factors of diagnosis rate.

Detailed Description
-----------------
The study will be conducted at about 10 clinical centers. Patients will be first screened, and only after meeting all the selection criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive BTPNA to sample the target lesions. The primary endpoint is the diagnostic yield of BTPNA. The secondary endpoints include the success rate of navigation, the operation time of the bronchoscope and so on.

Official Title
-----------------
A Single-arm, Prospective, Multicenter, Real-world Study to Evaluate the Safety and Efficacy of Bronchoscopic Transparenchymal Nodule Access (BTPNA) for the Diagnosis of Peripheral Lung Lesions

Conditions
-----------------
Peripheral Pulmonary Lesion

Intervention / Treatment
-----------------
* Device: Bronchoscopic Transparenchymal Nodule Access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years old. Newly diagnosed patients whose chest CT shows peripheral pulmonary lesions that have bronchus signs but are difficult to reach through the intrabronchial path, or are adjacent to the airway, or have no bronchus sign, and are suspected of malignancy which need non-surgical biopsies. The diameter of the lesions is greater than or equal to 0.8cm and less than 5cm The location of lesions results in the following situations where transthoracic needle aspiration (TTNA) is difficult to obtain a diagnosis or the operation is relatively risky, or have not been diagnosed by TTNA and other non-surgical biopsies in the past. Lesions can be accessed by BTPNA technology in preoperative assessment. Understand the research and sign the informed consent form. Exclusion Criteria: Contraindications for bronchoscopy. The lesions are adjacent to the target trachea or bronchus of points of entry(POE). Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery. Routine bronchoscopy showed visible lesions in the lumen. The investigator believes that the patient has other conditions that are not suitable for inclusion in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bronchoscopic Transparenchymal Nodule Access|Bronchoscopic Transparenchymal Nodule Access (BTPNA) is locating the lesion in the lung tissue guided by the bronchoscope navigation system (LungPro) in the natural lumen (bronchus), and automatically calculates the best point of entry (POE) and the best route to avoid blood vessels. An opening is made from the POE under the endoscope, and is extended with a balloon dilator. Combined with X-ray fluoroscopy, a sheath with a blunt-tip core is used in the lung parenchyma to reach the lesion site, and then biopsy diagnosis or treatment.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | Diagnostic yield is defined as the proportion of lesions diagnosed by BTPNA in all lesions undergoing bronchoscopy biopsy by BTPNA. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of navigation | The success rate of navigation is defined as the proportion of the number of lesions confirmed by ultrasound (and/or fluoroscopy) to the number of lesions in all BTPNA guided by the navigation system. | Immediately after bronchoscopic biopsy | 
| The success rate of biopsy | The success rate of biopsy is the number of lesions obtained by using BTPNA biopsy to obtain at least one qualified abnormal lung tissue sample that can be used for pathological diagnosis, divided by the total number of lesions obtained using BTPNA biopsy. | Immediately after bronchoscopic biopsy | 
| The operation time of the bronchoscope | The operation time of the bronchoscope is defined as the total time from insertion of the bronchoscope to withdrawal of the bronchoscope, not including the operation time of EBUS-TBNA. | Immediately after bronchoscopic biopsy | 
| The total time of lesion access | The total time of lesion access is defined as the total time from the insertion of the bronchoscope to the arrival confirmed by ultrasound probes (and/or fluoroscopy). | Immediately after bronchoscopic biopsy | 
| The intraoperative fluoroscopy time | The intraoperative fluoroscopy time is defined as the total fluoroscopy time (fluoroscopy reading) between the insertion of the bronchoscope and the withdrawal of the bronchoscope. | Immediately after bronchoscopic biopsy | 
| Factors affecting the diagnosis rate | Factors affecting the diagnosis rate, including the size of the lesions, the bronchial signs, the location of the lesions and so on will be analyzed. | Six months | 
| Factors affecting the biopsy success rate | Factors affecting the biopsy success rate, including the size of the lesions, the bronchial signs, the location of the lesions and so on will be analyzed. | Six months | 
| Factors affecting the navigation success rate | Factors affecting the navigation success rate, including the size of the lesions, the bronchial signs, the location of the lesions and so on will be analyzed. | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchoscopic Transparenchymal Nodule Access, Peripheral Pulmonary Lesion