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Phase II Clinical Study for Preoperative Assisted Localization of Small Pulmonary Nodules Guided by 3D Printing Template and CT

Phase II Clinical Study for Preoperative Assisted Localization of Small Pulmonary Nodules Guided by 3D Printing Template and CT

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025625
Enrollment
Unknown
Registered
2019-09-03
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary nodules

Interventions

Experimental group:3D Printing Template Combined with CT Guidance
control group :CT Guidanc

Sponsors

The First people's Hospital of Yueyang
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Pulmonary nodules were found by CT, which were more than 1.5 cm away from the pulmonary margin and less than 3 cm in diameter; 3. ECOG physical condition score 0-1, which was able to tolerate puncture; 4. Main organs were functioning well without severe hypertension, diabetes and heart disease. That is to say, within the first 14 days of randomization, the relevant examination indexes meet the following requirements: (1) blood routine examination: hemoglobin (>= 90 g/L) (no blood transfusion within 14 days); neutrophil count > 1.5x10^9/L; platelet count (>= 100x10^9/L); (2) biochemical tests: total bilirubin (= 60 ml/min) (Cockcroft-Gault formula); (3) Doppler echocardiography evaluation: left ventricular ejection fraction (LVEF) >= 50%; (4) blood sugar control in fasting blood sugar < 7.2 mmol/L, non-fasting blood sugar < 10 mmol/L, glycation Hemoglobin < 7%. 5. Sign the informed consent; Good compliance, family members agree to cooperate with survival follow-up.

Exclusion criteria

Exclusion criteria: (1) Patients with abnormal coagulation function and bleeding tendency (14 days before randomization must be satisfied: INR is within normal range without using anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; patients treated with international standardized ratio of prothrombin time (INR) less than 1.5 Subsequently, low-dose warfarin (1 mg orally, once a day) or aspirin (less than 100 mg daily) are allowed for preventive purposes; (2) those who have a history of psychotropic drug abuse and are unable to withdraw or have mental disorders; (3) arteriovenous thrombosis events such as cerebrovascular accidents (bags) occur within the first six months of screening. Including temporary ischemic attack, deep venous thrombosis (except for those who have been cured by venous catheterization due to pre-chemotherapy) and pulmonary embolism, etc.; (4) According to the judgement of the researchers, there are serious complications that endanger the safety of patients or affect patients to complete the study.

Design outcomes

Primary

MeasureTime frame
Location time;Location success rate;

Countries

China

Contacts

Public ContactXie Wangti

The First people's Hospital of Yueyang

xiewangi@163.com+86 18773006437

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026