Clinical trial NCT06962436: RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs
Official title: Robotic-Assisted Bronchoscopy Versus Ultrathin Bronchoscope Combined With Virtual Bronchoscopic Navigation for the Diagnosis of Peripheral Pulmonary Nodules: A Prospective, Multicenter, Randomized Controlled，Non-inferiority Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Pulmonary Nodules
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 184 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 diagnostic yield. Secondary endpoints include navigation success yield, arrival time, and incidence of complications.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic yield
timeFrame: 14 days post-procedure
Secondary outcomes:
measure: Navigation success yield
timeFrame: During the procedure
measure: Navigation time
timeFrame: During the procedure
measure: Incidence of complications
timeFrame: 14 days post-procedure
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Public Health Clinical Center
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital，Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun
role: STUDY_DIRECTOR
References: