Pulmonary nodules
Conditions
Interventions
Experimental group:Percutaneous lung needle biopsy using a navigation robotic system
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-80 years (inclusive), regardless of gender 2. with clinical and imaging diagnosis of a lung mass lesion and the need for a percutaneous biopsy 3. with good compliance and cooperation in completing CT-guided percutaneous lung puncture and other requirements of this study. 4. are able to voluntarily participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with uncorrectable coagulation disorders or on anticoagulation therapy. 2. Patients with bleeding tendencies. 3. Patients with severe cardiopulmonary insufficiency (e.g., severe pulmonary hypertension) or abnormal electrocardiogram within 1 week prior to surgery, presence of atrial fibrillation, severe myocardial ischemia or arrhythmia. 4. Patients with severe hepatic or renal insufficiency (glutamic aminotransferase (ALT) or glutamic oxalacetic aminotransferase (AST) > 5 times the upper limit of normal, alkaline phosphatase (ALP) > 5 times the upper limit of normal, total bilirubin (TBil) > 3 times the upper limit of normal, serum creatinine (Scr) > 178 µmol/L ), combined with other clinical manifestations, as determined by the investigator. 5. Patients with severe emphysema, pulmonary bulla, pulmonary fibrosis, or chronic obstructive pulmonary disease that lung puncture is contraindicated 6. Patients with suspected intrapulmonary cystic lesions, such as pulmonary encapsulopathy 7. Pregnant or lactating women. 8. Patients using devices that are subject to electromagnetic interference (e.g., pacemakers) or implants that cause electromagnetic interference 9. Patients with a previous medical history of allergy to enhanced CT contrast agents 10. Patients with other contraindications for CT-guided needle biopsy or who are otherwise deemed unsuitable for enrollment by their physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate, needle reposition less than 2 times; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate, needle reposition less than 1 times;aiming accuracy of puncture;Number of CT aqusitions, when needle successfully placed;Fuctional assessment; | — |
Countries
China
Contacts
Public ContactCaicun Zhou
Shanghai Pulmonary Hospital
Outcome results
None listed