To evaluate the safety and efficacy of surgical navigation systems in thoracoabdominal puncture surgery--a multicenter, randomized controlled, superiority clinical trial

Not Applicable

Recruiting

• Conditions: Space occupying lesions in the chest and abdomen

• Registration Number: ChiCTR2400088885
• Lead Sponsor: Peking Union Medical College Hospital ,Chinese Academy of Medical Sciences/Renji Hospital, Shanghai Jiaotong University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with thoracic and abdominal space-occupying lesions requiring CT-guided percutaneous puncture surgery;<br>2) Age = 18 years old, male or female;<br>3) Voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion Criteria

1. The size (maximum diameter) of the lung lesion during chest puncture is less than 8mm<br><br>2) There is a clear tendency for bleeding or severe coagulation dysfunction that cannot be corrected, as well as diseases that may lead to coagulation dysfunction (platelet count<50 × 109/L, INR = 1.5)<br>3) Aspirin and clopidogrel should not be suspended within 1 week before surgery, warfarin should not be suspended within 5 days before surgery, low molecular weight heparin should not be suspended within 24 hours before surgery, and conventional heparin treatment should not be suspended within 6 hours before surgery<br>4) Anlotinib should not be suspended within 1 week before surgery, recombinant human endostatin treatment should not be suspended within 24 hours before surgery, and bevacizumab anti angiogenic drugs should not be suspended within 4 weeks before surgery<br> 5) Clinical considerations include hepatic hemangioma and hepatic multilocular echinococcosis, and abdominal puncture cannot be performed<br>6) Referring to imaging examination, the researcher judged the lack of a safe puncture path<br> 7) Patients who have been trained to be unable to use respiratory tracking systems and have been determined by researchers to require general anesthesia but cannot tolerate it<br> 8) Suffering from known mental illness or drug abuse disorders that make it difficult for subjects to comply with the requirements of the trial<br> 9) Patients with systemic systemic infections<br>10) Pregnant or lactating women<br>11) Screening patients who are currently participating in any other clinical trials within the first two weeks<br>12) Researchers believe that any illness, medical history or current evidence of treatment or laboratory abnormalities that may confuse the trial results, interfere with the subject's participation throughout the entire trial period, or make participation in the trial not in the subject's best interest.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The success rate of one puncture;

Secondary Outcome Measures

Name	Time	Method
The success rate of second or more punctures;CT scan count;Device defect incidence rate (%) and frequency (number of events);Vital signs;The incidence (%) and frequency (number of events) of adverse events (ae) and severe adverse events;The incidence rate (%) and frequency (number of events) of concurrent symptoms;Absolute positioning error of surgical needle;Operation time;Relative position error of surgical needle;Needle angle error;Evaluation of test device use;Dose length product (DLP);