Peripheral Pulmonary LesionNCT04597346
Evaluate the Diagnostic Value of BTPNA for PPL: a Real-world Study
An observational study of Peripheral Pulmonary Lesion, run by Shanghai Chest Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Pulmonary Lesion
- What is being tested?
- Bronchoscopic Transparenchymal Nodule Access
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2021to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients older than 18 years old.
- 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.
- The diameter of the lesions is greater than or equal to 0.8cm and less than 5cm
- 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.
- Lesions can be accessed by BTPNA technology in preoperative assessment.
- Understand the research and sign the informed consent form.
Who cannot join
- Contraindications for bronchoscopy.
- The lesions are adjacent to the target trachea or bronchus of points of entry(POE).
- Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery.
- Routine bronchoscopy showed visible lesions in the lumen.
- The investigator believes that the patient has other conditions that are not suitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country.
Jiayuan Sun, MD, PhD contact
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Jiayuan Sun, MD, PhD, 86-021-22200000 ext. 1511, xkyyjysun@163.com
About this 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
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.
Read the 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.
- Conditions
- Peripheral Pulmonary Lesion
- Being tested
- Bronchoscopic Transparenchymal Nodule Access
- Keywords
- Bronchoscopic Transparenchymal Nodule Access, Peripheral Pulmonary Lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic Transparenchymal Nodule AccessDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Diagnostic yield is defined as the proportion of lesions diagnosed by BTPNA in all lesions undergoing bronchoscopy biopsy by BTPNA.
Measured: Six months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start23 Dec 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peripheral Pulmonary LesionStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Beijing Chao Yang Hospital, Shandong Public Health Clinical Center, West China Hospital, Second Affiliated Hospital of Guangzhou Medical University, Xi'an International Medical Center Hospital, Emergency General Hospital
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD, PhD, Study director, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597346
- Sponsor's protocol ID
- SHCHE202003
- Status last verified
- Feb 2023
- First submitted
- 14 Oct 2020
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 8617067Baaklini 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.
PubMed 10767238Tamiya 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.
PubMed 23586738Gilbert 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.
PubMed 24797257Sterman 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.
PubMed 25275338Herth 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.
PubMed 25746631Harzheim 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.
PubMed 27007334
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04597346
- Acronym / sponsor ID
- SHCHE202003
- Conditions
- Peripheral Pulmonary Lesion
- Keywords
- Bronchoscopic Transparenchymal Nodule Access, Peripheral Pulmonary Lesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Beijing Chao Yang Hospital, Shandong Public Health Clinical Center, West China Hospital, Second Affiliated Hospital of Guangzhou Medical University, Xi'an International Medical Center Hospital, Emergency General Hospital
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Patients older than 18 years old.
- 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.
- The diameter of the lesions is greater than or equal to 0.8cm and less than 5cm
- 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.
- Lesions can be accessed by BTPNA technology in preoperative assessment.
Key exclusion criteria (5 listed)
- Contraindications for bronchoscopy.
- The lesions are adjacent to the target trachea or bronchus of points of entry(POE).
- Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery.
- Routine bronchoscopy showed visible lesions in the lumen.
- The investigator believes that the patient has other conditions that are not suitable for inclusion in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscopic Transparenchymal Nodule AccessBronchoscopic 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. | Device | – |
Primary outcome
Diagnostic yield
Time frame: Six months
Diagnostic yield is defined as the proportion of lesions diagnosed by BTPNA in all lesions undergoing bronchoscopy biopsy by BTPNA.
8 secondary outcomes
The success rate of navigation
Time frame: Immediately after bronchoscopic biopsy
The success rate of biopsy
Time frame: Immediately after bronchoscopic biopsy
The operation time of the bronchoscope
Time frame: Immediately after bronchoscopic biopsy
The total time of lesion access
Time frame: Immediately after bronchoscopic biopsy
The intraoperative fluoroscopy time
Time frame: Immediately after bronchoscopic biopsy
Factors affecting the diagnosis rate
Time frame: Six months
Factors affecting the biopsy success rate
Time frame: Six months
Factors affecting the navigation success rate
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Results publication: PubMed 8617067Chechani 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.
- Results publication: PubMed 10767238Baaklini 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.
- Results publication: PubMed 23586738Tamiya 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.
- Results publication: PubMed 24797257Gilbert 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.
- Results publication: PubMed 25275338Sterman 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.
- Results publication: PubMed 25746631Herth 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.
- Results publication: PubMed 27007334Harzheim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiayuan Sun, MD, PhD contact
Jiayuan Sun, MD, PhD study director
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Pulmonary Lesion, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun, MD, PhD (86-021-22200000 ext. 1511, xkyyjysun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04597346, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.