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

Peripheral Pulmonary Lesion Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04597346
• Other study ID #: SHCHE202003
• Status: Recruiting
• Start date: December 23, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2023
• Source: Shanghai Chest Hospital
• Contact: Jiayuan Sun, MD, PhD
• Phone: 86-021-22200000
• Email: xkyyjysun[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Pulmonary Lesion

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (8)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	Beijing Chao Yang Hospital, Emergency General Hospital, Henan Provincial People's Hospital, Second Affiliated Hospital of Guangzhou Medical University, Shandong Public Health Clinical Center, West China Hospital, Xi 'an International Medical Center Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Baaklini WA, Reinoso MA, Gorin AB, Sharafkaneh A, Manian P. Diagnostic yield of fiberoptic bronchoscopy in evaluating solitary pulmonary nodules. Chest. 2000 Apr;117(4):1049-54. doi: 10.1378/chest.117.4.1049. — View Citation

Chechani V. Bronchoscopic diagnosis of solitary pulmonary nodules and lung masses in the absence of endobronchial abnormality. Chest. 1996 Mar;109(3):620-5. doi: 10.1378/chest.109.3.620. — View Citation

Gilbert C, Akulian J, Ortiz R, Lee H, Yarmus L. Novel bronchoscopic strategies for the diagnosis of peripheral lung lesions: present techniques and future directions. Respirology. 2014 Jul;19(5):636-44. doi: 10.1111/resp.12301. Epub 2014 May 6. — View 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. — View 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/thora — View Citation

Sterman DH, Keast T, Rai L, Gibbs J, Wibowo H, Draper J, Herth FJ, Silvestri GA. High yield of bronchoscopic transparenchymal nodule access real-time image-guided sampling in a novel model of small pulmonary nodules in canines. Chest. 2015 Mar;147(3):700- — View Citation

Tamiya M, Okamoto N, Sasada S, Shiroyama T, Morishita N, Suzuki H, Yoshida E, Hirashima T, Kawahara K, Kawase I. Diagnostic yield of combined bronchoscopy and endobronchial ultrasonography, under LungPoint guidance for small peripheral pulmonary lesions. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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