Lung Cancer (Diagnosis), Percutaneous Needle Biopsy, Pulmonary Nodules, Robotic Assisted Intervention, Transthoracic Needle Biopsy
Conditions
Keywords
Percutaneous Needle Biopsy, Transthoracic Needle Biopsy, Pulmonary Nodules, Lung Cancer (Diagnosis), Robotic Assisted Intervention
Brief summary
This prospective, single-center, non-inferiority, randomized controlled clinical trial aims to evaluate the efficacy and safety of a percutaneous interventional surgical control system in performing percutaneous needle biopsy of pulmonary nodules, compared with conventional manual biopsy. The study will be conducted at Shanghai Chest Hospital and plans to enroll 158 patients who meet the indications for percutaneous transthoracic needle biopsy (PTNB) and have no contraindications. Participants will be randomly assigned to one of two groups: the experimental group will undergo PTNB assisted by the percutaneous interventional surgical control system, while the control group will receive traditional manual PTNB. The primary endpoint is diagnostic yield; secondary endpoints include technical success rate, number of needle adjustments, puncture time, total procedure time, radiation dose, and complication rates.
Interventions
DIAGNOSTIC_TESTPercutaneous Needle Biopsy with Interventional Surgical Control System
Patients undergo percutaneous needle biopsy of pulmonary nodules with assistance from a percutaneous interventional surgical control system. The system performs automatically needle positioning and puncture.
DIAGNOSTIC_TESTConventional Manual Percutaneous Needle Biopsy
Patients receive traditional manual percutaneous needle biopsy of pulmonary nodules under CT guidance, operated by experienced interventional physicians.
Sponsors
Shanghai United Imaging Intelligence Co., Ltd
Jiayuan Sun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1\) Age ranging from 18 years old to 80 years old, gender not restricted; 2) Patients with pulmonary nodules detected by chest CT, suspected to be malignant and judged by the researchers to require puncture biopsy for a clear diagnosis; 3) Pulmonary nodules with a long diameter greater than 8mm but not exceeding 30mm; 4) Have signed the informed consent form and voluntarily participate in this clinical study; 5) Can understand this research and cooperate with the research procedures, and can follow the requirements for follow-up observation.
Exclusion criteria
1\) Subjects with irreparable coagulation dysfunction, infectious lesions on the puncture path, lesions adjacent to organs or surrounded by large blood vessels, suspected pulmonary echinococcosis on imaging, patients on mechanical ventilation (with a ventilator), liver multilocular echinococcosis, coma or other patients who are uncooperative; 2) Those judged by the investigators to be unsuitable for chest percutaneous puncture surgery: such as severe pulmonary hypertension, pulmonary bullae, chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis; 3) Poor overall condition (multiple systemic metastases, severe infection, high fever), obvious cachexia, severe dysfunction of important organs, severe anemia and nutritional metabolic disorders that cannot be improved in the short term; 4) Those allergic to contrast agents or anesthetics; 5) Implantation of pacemakers; 6) Pregnant or lactating women, or those with a fertility plan during the clinical trial; 7) Patients who cannot cooperate with the doctor to complete the puncture surgery, such as known drug or alcohol addiction, mental and neurological diseases, intellectual disability, psychological disorders, etc.; 8) Those participating in another drug or medical device clinical trial (within 3 months of drug clinical trial or within 1 month of medical device clinical trial); 9) The target lesion has been diagnosed or has received treatment; 10) Other situations that the investigator deems not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dianostic yield | Up to 6 months after biopsy | Malignant lesions and specific benign lesions (e.g., fungal infections, tuberculosis, granulomas, etc.) are considered as having a definitive diagnosis. Non-specific benign lesions (e.g., inflammation) are deemed diagnosed if they are confirmed by at least 6 months of follow-up, surgical resection, other biopsy methods, or radiological follow-up showing lesion shrinkage or disappearance. Atypical cells or normal lung tissue are classified as non-diagnostic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Needle Adjustments | Intra-operative | The number of needle adjustments from the moment the first needle tip touches the skin until the researcher confirms the puncture is successful, recorded by the investigator during the procedure. Any change in puncture direction, needle withdrawal, or needle removal after needle insertion should be counted. |
| Puncture time | Intra-operative | Refers to the duration from when the needle tip first reaches the skin puncture site to when successful puncture is confirmed (i.e., when the investigator judges that biopsy can be performed based on intra-operative CT scan). |
| Technical Success Rate | Intra-operative | Defined as the successful positioning of the biopsy needle to the target lesion by the investigator based on intra-operative CT, without the use of other auxiliary puncture tools or needle guidance techniques. If yes, it is defined as technically successful. Technical success rate = (Number of patients with technical success / Total number of participants) × 100%. |
| Complication rate | Up to 6 months after biopsy | Common complications of percutaneous needle biopsy include puncture site infection, pneumothorax, bleeding, hemoptysis, pleural reaction, etc. Rare complications include air embolism, cardiac tamponade, tumor seeding along the needle tract, nerve injury, etc. |
| Radiation dose | Intra-operative | The radiation dose received by the patient as recorded by the CT scan protocol during the biopsy procedure |
| Procedural Time | Intra-operative | Refers to the total time from when the patient is positioned to when the procedure is completed. |
Countries
China
Contacts
Primary ContactJiayuan Sun, PhD
Outcome results
None listed