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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Pulmonary Lesion
• Intervention / Treatment: Device: Bronchoscopic Transparenchymal Nodule Access

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Jiayuan Sun, MD, PhD; Phone Number: 1511 86-021-22200000; Email: xkyyjysun@163.com
• Study Contact Backup: Name: Jiayuan Sun, MD, PhD

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Jiayuan Sun, MD, PhD; Phone Number: 1511 86-021-22200000; Email: xkyyjysun@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Respirology. 2013 Jul;18(5):834-9. doi: 10.1111/resp.12095.
• 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.
• 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):700-707. doi: 10.1378/chest.14-0724.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2021
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Peripheral Pulmonary Lesion; Bronchoscopic Transparenchymal Nodule Access
• Other Study ID Numbers: SHCHE202003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO