SH-LPS System in Preoperative Planning for Liver Resection

Phase 2

Not yet recruiting

• Conditions: Liver Tumor; Surgery; 3D Printing; Preoperative Planning

• Registration Number: NCT06911086
• Lead Sponsor: Zhejiang Cancer Hospital

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 liver models using a self-healing elastomer, created through the copolymerization of 4-acryloylmorpholine (ACMO) and methoxy poly(ethylene glycol) acrylate (mPEGA). These models demonstrate outstanding healing properties, swiftly restoring their structure within minutes at room temperature, and quickly recovering after incisions.

In previous studies, Professor Yuhua Zhang, the project applicant, collaborated with a team from Zhejiang University to develop a 3D-printed liver model that is self-healing and reusable for repeated cutting. They preliminarily explored the feasibility of applying this model for preoperative planning and surgical training for liver surgeries. The results were published in Nature Communications (Lu et al., Nat Commun. Dec 19;14(1):8447). Building on this, the applicant intends to establish a personalized liver surgery planning system (Personalized Liver Surgery Planning System Based on High-Fidelity 3D Printed Self-Healing Liver Models, SH-LPS), which will assess, through a randomized controlled trial, the value of SH-LPS in improving liver surgery efficiency and safety.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-05
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Study Start: 2025-04-15
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Opertation duration	Until the end of the surgey	The duration from the start to the end of the surgery.
Blood loss	Until the end of the surgey	Blood loss during the operation

Secondary Outcome Measures

Name	Time	Method
R0 resection rate	Until the day the official pathology report comes out, an average of two weeks	The percentage of surgical cases in which the tumor is completely removed with no microscopic residual cancer cells left at the margins of the resected tissue
Surgical complications	Until three months after the surgery	The incidence rate of surgical complications
Postoperative hospital stay.	Until the day the patient is discharged, an average of one week.	Postoperative hospital stay refers to the period of time a patient remains in the hospital after undergoing surgery, until they are medically stable and deemed fit for discharge.