RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs

Not Applicable

Not yet recruiting

• Conditions: Peripheral Pulmonary Nodules

• Registration Number: NCT06962436
• Lead Sponsor: Shanghai Chest Hospital

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study Start: 2025-05
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	14 days post-procedure	Diagnostic yield= (number of nodules diagnosed with malignancies or specific benign results by study procedure / total number of nodules biopsied by bronchoscopy in each group) \* 100%

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Shandong Public Health Clinical Center; 🇨🇳 Jinan, Shandong, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

Zhongshan Hospital，Fudan University; 🇨🇳 Shanghai, Shanghai, China

Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China