Status:
UNKNOWN
3D Printed Models for Liver Surgery
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Liver Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Comprehensive preoperative planning and real-time intraoperative guidance are essential prerequisites for achieving precise liver resection. In pursuit of this goal, the investigators have developed i...
Eligibility Criteria
Inclusion
- 18-80 years old;
- Patients with a resectable tumor in the liver;
- Eastern Cooperative Oncology Group Performance status score: 0;
- Child-Pugh classification: A;
- The Laboratory test results meet the following criteria and patients can tolerate surgery: Haemoglobin≥90g/L, Neutrophil count≥1.5×10⁹/L, Platelet count≥100×10⁹/L, Aspartate or alanine aminotransferase≤5 upper limits of normal(ULN), alkaline phosphatase≤2.5 ULN, Serum albumin≥30g/L, serum creatinine\<1.5 ULN, International normalized ratios(INR)≤2 or Prothrombin time(PT)exceed ULN≤6s, Creatinine clearance≥60 mL/min.
Exclusion
- Patients with extra-hepatic metastasis;
- Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation in 28 days prior to the surgery;
- Clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy;
- Severe lung disease (eg, acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease), uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L);
- There are other unsuitable candidates for clinical trials, such as mental illness or alcohol dependence.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 29 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06006338
Start Date
September 15 2023
End Date
February 29 2024
Last Update
September 21 2023
Active Locations (1)
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1
1# Banshan East Rd. Zhejiang cancer hospital
Hangzhou, Zhejiang, China, 310022