Status:
NOT_YET_RECRUITING
SH-LPS System in Preoperative Planning for Liver Resection
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Liver Tumor; Surgery
3D Printing
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Effective preoperative planning and real-time intraoperative guidance are crucial for performing accurate liver resections. To address this need, the researchers have designed advanced 3D-printed live...
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 rothrombin 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 :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06911086
Start Date
April 15 2025
End Date
June 1 2026
Last Update
April 4 2025
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