Peripheral Pulmonary Nodules
Conditions
Brief summary
The purpose of this study is to evaluate whether the diagnostic yield of robotic-assisted bronchoscopy is not inferior to that of the virtual bronchoscopic navigation combined with ultrathin bronchoscopy.
Detailed description
This is an investigator-initiated, prospective, multicenter, randomized , non-inferiority clinical trial, with a total of 186 participants planned for enrollment. Subjects with peripheral pulmonary nodules (PPNs) suspected of malignancy, requiring non-surgical biopsy detected by chest CT will be included in this study. Firstly, the physician will determine the lesion to be biopsied, then the subject will be randomly assigned to either the experimental or control group. The experimental group will undergo the procedure using the robotic-assisted bronchoscopy system and catheters, developed by Changzhou Langhe Medical Devices Co., Ltd. for the localization and sampling of PPNs. The control group will undergo ultrathin bronchoscopy guided by virtual bronchoscopic navigation. Radial endobronchial ultrasound (r-EBUS) will be available for all procedures. If the physician determines that biopsy sampling is feasible, a transbronchial lung biopsy will be performed. The primary endpoint is the intermediate definition of diagnostic yield. Secondary endpoints include navigation success yield, arrival time, incidence of complications, and strict definition of diagnostic yield.
Interventions
Utilization of a robotic bronchoscopy system for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
DEVICEUltrathin bronchoscope combined with virtual bronchoscopic navigation
Utilization of ultrathin bronchoscope combined with virtual bronchoscopic navigation for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years, regardless of gender; 2. Patients with peripheral lung nodules of suspected malignancy on chest CT who require non-surgical biopsy; 3. Patients who voluntarily consent to undergo bronchoscopy and meet the requirements for the bronchoscopy; 4. Patients should understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.
Exclusion criteria
1. Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count \<60×10\^9/L), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion; 2. Patients with pure ground-glass nodules suspected of malignancy on chest CT; 3. Female patients who are breastfeeding, pregnant, or planning pregnancy; 4. Patients with electromagnetic active implantable medical devices; 5. Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history; 6. Those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days; 7. Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 14 days post-procedure | Intermediate definition of diagnostic yield=(Number of procedures with a specific malignant or benign pathological diagnosis+Number of procedures with nonspecific benign diagnoses that turn out to be nonmalignant at follow-up)/Total number of patients in whom the minimally invasive procedure was attempted or performed\*100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Navigation success yield | During the procedure | Navigation success yield = (number of nodules successfully navigated / total number of nodules biopsied by bronchoscopy in each group) \* 100% |
| Navigation time | During the procedure | In the experimental group, the navigation time is measured from the tracheal carina after the registration to the moment the lesion is visible at the front-end camera of the catheter or confirmed by r-EBUS. In the control group, the navigation time is measured from the tracheal carina to the moment the lesion is confirmed by r-EBUS. |
| Incidence of complications | 14 days post-procedure | Incidence of complications = (number of cases with complications / total number of sampled cases) \* 100%. Complications are categorized according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and include events such as pneumothorax and bleeding. |
| Strict definition of diagnostic yield | 14 days post-procedure | Strict definition of diagnostic yield=(Number of procedures with a specific malignant or benign pathological diagnosis)/Total number of patients in whom the minimally invasive procedure was attempted or performed\*100% |
Countries
China
Contacts
CONTACTXiaoxuan Zheng
STUDY_DIRECTORJiayuan Sun
Shanghai Chest Hospital
Outcome results
None listed