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| Name | Class |
|---|---|
| Henan Provincial People's Hospital | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Shandong Public Health Clinical Center | OTHER_GOV |
| West China Hospital |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoscopic Transparenchymal Nodule Access | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun, MD, PhD | Contact | 86-021-22200000 | 1511 | xkyyjysun@163.com |
| Jiayuan Sun, MD, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Jiayuan Sun, MD, PhD | Shanghai Chest Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8617067 | Result | 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. | |
| 10767238 | Result | 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. |
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| OTHER |
| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
| Xi'an International Medical Center Hospital | OTHER |
| Emergency General Hospital | OTHER |
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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 |
| 23586738 | Result | 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. |
| 24797257 | Result | Gilbert C, Akulian J, Amador RO, 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. |
| 25275338 | Result | 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. |
| 25746631 | Result | 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. |
| 27007334 | Result | 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. |