Clinical trial NCT04597346: Evaluate the Diagnostic Value of BTPNA for PPL: a Real-world Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Pulmonary Lesion
Keywords: Bronchoscopic Transparenchymal Nodule Access
Peripheral Pulmonary Lesion
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Henan Provincial People's Hospital
name: Beijing Chao Yang Hospital
name: Shandong Public Health Clinical Center
name: West China Hospital
name: Second Affiliated Hospital of Guangzhou Medical University
name: Xi 'an International Medical Center Hospital
name: Emergency General Hospital
First posted: 2020-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed patients whose chest CT showed suspect malignant peripheral lung lesion and are scheduled to receive non-surgical biopsies with lesion access via BTPNA.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years old.
2. 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.
3. The diameter of the lesions is greater than or equal to 0.8cm and less than 5cm
4. 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.
5. Lesions can be accessed by BTPNA technology in preoperative assessment.
6. Understand the research and sign the informed consent form.

Exclusion Criteria:

1. Contraindications for bronchoscopy.
2. The lesions are adjacent to the target trachea or bronchus of points of entry(POE).
3. Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery.
4. Routine bronchoscopy showed visible lesions in the lumen.
5. The investigator believes that the patient has other conditions that are not suitable for inclusion in this study.

Primary outcomes:
measure: Diagnostic yield
timeFrame: Six months
Secondary outcomes:
measure: The success rate of navigation
timeFrame: Immediately after bronchoscopic biopsy
measure: The success rate of biopsy
timeFrame: Immediately after bronchoscopic biopsy
measure: The operation time of the bronchoscope
timeFrame: Immediately after bronchoscopic biopsy
measure: The total time of lesion access
timeFrame: Immediately after bronchoscopic biopsy
measure: The intraoperative fluoroscopy time
timeFrame: Immediately after bronchoscopic biopsy
measure: Factors affecting the diagnosis rate
timeFrame: Six months
measure: Factors affecting the biopsy success rate
timeFrame: Six months
measure: Factors affecting the navigation success rate
timeFrame: Six months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD, PhD
role: STUDY_DIRECTOR
References:
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citation: Herth FJ, Eberhardt R, Sterman D, Silvestri GA, Hoffmann H, Shah PL. Bronchoscopic transparenchymal nodule access (BTPNA): first in human trial of a novel procedure for sampling solitary pulmonary nodules. Thorax. 2015 Apr;70(4):326-32. doi: 10.1136/thoraxjnl-2014-206211. Epub 2015 Mar 6.
citation: Harzheim D, Sterman D, Shah PL, Eberhardt R, Herth FJ. Bronchoscopic Transparenchymal Nodule Access: Feasibility and Safety in an Endoscopic Unit. Respiration. 2016;91(4):302-6. doi: 10.1159/000445032. Epub 2016 Mar 24.