SH-LPS System in Preoperative Planning for Liver Resection

Launched by ZHEJIANG CANCER HOSPITAL · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial, called SH-LPS, is studying a new way to plan and guide liver surgery using advanced 3D-printed models of the liver. These models are made from a special material that can heal itself after being cut, which helps doctors practice and prepare for surgery more effectively. The researchers want to find out if using these models can make liver surgeries safer and more efficient for patients with tumors that can be removed.

To participate in this trial, you need to be between 18 and 80 years old and have a liver tumor that can be surgically removed. You should be in generally good health, with certain lab test results showing your body can handle surgery. However, people with certain other health issues or who have received recent cancer treatments may not be eligible. If you decide to join, you can expect to help researchers understand how this innovative planning system can improve surgical outcomes. Your participation could contribute to better liver surgery techniques for future patients!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.