Peripheral Pulmonary Lesions (PPLs), Pulmonary Nodules
Conditions
Keywords
Rotational Cryobiopsy Needle, Automated Biopsy Needle, Diagnostic Yield, Peripheral Pulmonary Lesions
Brief summary
This study aims to systematically compare the diagnostic efficacy, specimen quality, and complication rates of the cryobiopsy needle technique（CassiII rotational core biopsy） versus the automated biopsy technique in the biopsy of pulmonary nodules, thereby providing a reliable evidentiary basis for clinical practice.
Interventions
PROCEDURECassiII rotational core biopsy
CassiII rotational core biopsy needle is inserted in lesion site, ≥1 biopsy is performed.
PROCEDUREAutomated biopsy
Automated biopsy needle is inserted in lesion site, ≥1 biopsy is performed.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Intervention model description
This study employed a prospective, randomized, single-blind, parallel-group, single-center trial design, enrolling consecutive patients with peripheral pulmonary nodules of unknown etiology. The subjects were randomly assigned (1:1) to either the CassiII rotational core biopsy group (experimental group) or the automated biopsy needle group (control group).
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* If a chest CT scan reveals pulmonary nodules with an unknown nature, a biopsy is required for definitive diagnosis; if the chest CT shows multiple pulmonary nodules, one of these nodules should be selected as the target lesion; * Axial chest CT imaging demonstrates peripheral pulmonary nodules located in the pulmonary region, with diameters ranging from 8 mm to 30 mm; ③Voluntarily undergo CT-guided lung puncture biopsy and meet all preoperative requirements; ④Participants demonstrate good compliance, are able to cooperate with the study observations, are fully informed about the study's objectives and methods, acknowledge the potential risks, agree to participate in the study, and sign the informed consent form.
Exclusion criteria
* Severe cardiopulmonary dysfunction; * Irreversible coagulation disorders; * Suspected vascular lesions or arteriovenous malformations (assessed by contrast-enhanced CT), or presence of bronchial artery penetration at the planned biopsy site, or suspected pulmonary metastasis from renal cell carcinoma, indicating a high risk of hemorrhage; * PET-CT findings indicate a malignant pulmonary nodule; surgical evaluation may prioritize surgical intervention for the patient; * Pregnant or lactating women; ⑥ Patients with psychiatric disorders or those unable to cooperate during the puncture procedure; ⑦ Presence of anesthesia contraindications; allergy to anesthetic agents; or a history of multiple severe allergies or hereditary allergies; * If the participant has participated in other studies within the past three months without withdrawing or completing those studies, this will affect the observation of the present study; ⑨ Refusal to participate in this study, unwillingness to accept the follow-up protocol, or other circumstances in which the investigator deems the participant unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield of the two biopsy methods | From enrollment to the end of procedure at 2 years | Diagnostic yield = (Number of pathologically positive cases / Total number of enrolled cases) × 100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consistency analysis between AI-ROSE results and pathological results | From enrollment to the end of procedure at 2 years | The results of AI-ROSE were compared with the pathological results, and the consistency analysis was performed to evaluate the effectiveness of AI-ROSE |
| Safety indicators | From enrollment to the end of procedure at 2 years | Complications: Incidence (including pneumothorax, hemorrhage, respiratory failure, infection, and severe complications requiring endotracheal intubation and mechanical ventilation to be transferred to the Intensive Care Unit), severity levels, and corresponding management measures. |
| Specimen size | From enrollment to the end of procedure at 2 years | biopsy tissue size (long diameter, millimeter) |
Countries
China
Outcome results
None listed