Peripheral Pulmonary Lesion
Conditions
Brief summary
The goal of this clinical trial is tois to assess the effectiveness and safety of RBS (Robotic Bronchoscopy System)-assisted cryobiopsy in real-world clinical settings in adult patients (aged ≥18 years) with suspected pulmonary lesions requiring diagnostic bronchoscopic evaluation. The main questions it aims to answer are: Does RBS-assisted cryobiopsy improve diagnostic yield compared to conventional non-RBS-guided cryobiopsy? Is RBS-assisted cryobiopsy associated with a lower incidence of procedure-related complications (e.g., bleeding, pneumothorax) compared to conventional methods? Researchers will compare the RBS group (patients undergoing RBS-assisted cryobiopsy) with the control group (patients undergoing cryobiopsy with conventional navigation techniques, such as ENB, VBN) to evaluate differences in diagnostic accuracy and safety outcomes. Participants will: Provide informed consent for bronchoscopic cryobiopsy. Undergo pre-procedure imaging and clinical evaluation. Receive either RBS-assisted or conventional cryobiopsy based on clinical indication and operator discretion. Be monitored for immediate and delayed complications .
Interventions
PROCEDUREunicorn robotic bronchoscopy system
cryobiopsy with the help of robotic bronchoscopy system
PROCEDUREConventional navigation bronchoscopy
cryobiopsy with the help of Conventional navigation bronchoscopy
Sponsors
Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: * Patients are eligible for inclusion if they meet all of the following criteria: 1. Age ≥18 years and ≤75 years, with no gender restrictions; 2. Presence of a peripheral lung lesion on chest CT 3. Patients voluntarily agree to undergo bronchoscopy and meet the requirements for the procedure; 4. patients are capable of understanding the purpose of the trial, demonstrate good compliance with the examinations and follow-up, voluntarily participate in the clinical trial, and sign an informed consent form.
Exclusion criteria
* Patients who meet any of the following criteria will be excluded from this study: 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. Female patients who are breastfeeding, pregnant, or planning pregnancy; 3. Patients with electromagnetic active implantable medical devices; 4. Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history; 5. 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; 6. Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall diagnostic yield | 6 months after biopsy | Overall diagnostic yield was considered as the primary outcome, defined as the number of cases in which the diagnosis of bronchoscopy matched the final diagnosis, divided by the total number of completed cases during follow-up. A lesion was considered malignant if tumor cells were found in histological and/or cytological specimens. It was considered benign if pathological evaluation showed specific benign pathology and/or non-specific benign lesions confirmed by MDT discussion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Navigation success rate | During the bronchoscopy | The success rate of navigation = (the number of lesions judged as successfully navigated / the total number of lesions undergoing transbronchial lung biopsy) \* 100%. The criteria for judging successful navigation: if the lesion edge is confirmed by imaging equipment and the researcher deems it feasible for biopsy, it is considered a successful navigation; otherwise, it is regarded as a failed navigation. For those with a clear diagnosis through the research procedure, all are considered successful navigation. |
Contacts
Primary ContactChanghao Zhong
Outcome results
None listed