Evaluate the Diagnostic Value of BTPNA for PPL: a Real-world Study
NCT ID: NCT04597346
Last Updated: 2023-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2021-12-23
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Henan Provincial People's Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Shandong Public Health Clinical Center
OTHER_GOV
West China Hospital
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
Xi 'an International Medical Center Hospital
UNKNOWN
Emergency General Hospital
OTHER
Shanghai Chest Hospital
OTHER
Responsible Party
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Jiayuan Sun
Director, Department of Respiratory Endoscopy
Principal Investigators
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Jiayuan Sun, MD, PhD
Role: STUDY_DIRECTOR
Shanghai Chest Hospital
Locations
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Jiayuan Sun, MD, PhD
Role: CONTACT
Facility Contacts
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References
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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.
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.
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, 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.
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.
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.
Other Identifiers
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SHCHE202003
Identifier Type: -
Identifier Source: org_study_id
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