RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs
ConditionPeripheral Pulmonary Nodules
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, regardless of gender;
Patients with peripheral lung nodules of suspected malignancy on chest CT who require non-surgical biopsy;
Patients who voluntarily consent to undergo bronchoscopy and meet the requirements for the bronchoscopy;
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.
Disqualifiers
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;
Patients with pure ground-glass nodules suspected of malignancy on chest CT;
Female patients who are breastfeeding, pregnant, or planning pregnancy;
Patients with electromagnetic active implantable medical devices;
Trial design
Design model
Parallel
Treatments tested in this trial
Robotic bronchoscopy system
DeviceUtilization of a robotic bronchoscopy system for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
Ultrathin bronchoscope combined with virtual bronchoscopic navigation
DeviceUtilization of ultrathin bronchoscope combined with virtual bronchoscopic navigation for the biopsy of patients with peripheral pulmonary lesions suspected of malignancy
Treatment groups
186 Participants
are divided into 2 treatment groupsGroup A: RAB groupExperimental treatment 1 intervention
Group B: UB-VBN groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic yield
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%
Time frame
14 days post-procedureSecondary outcomes
1
Navigation success yield
Navigation success yield = (number of nodules successfully navigated / total number of nodules biopsied by bronchoscopy in each group) \* 100%
Time frame
During the procedure2
Navigation time
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.
Time frame
During the procedure3
Incidence of complications
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.
Time frame
14 days post-procedure4
Strict definition of diagnostic yield
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%
Time frame
14 days post-procedureSponsors and contacts
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Source ClinicalTrials.gov