SH-LPS System in Preoperative Planning for Liver Resection

NCT ID: NCT06911086

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2026-06-01

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.

Conditions

Liver Tumor; Surgery; 3D Printing; Preoperative Planning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

3D group

A three-dimensional digital model is constructed based on the patient's CT/MRI data and a physical model is printed. Using the model's self-healing property after cutting, multiple simulated surgeries are performed to help plan the optimal surgical approach. The best surgical path derived from the model is combined with traditional CT/MRI data to determine the final surgical path, and the surgery is then performed according to this finalized path.

Group Type: EXPERIMENTAL

3D printed models

Intervention Type: DEVICE

A three-dimensional digital model is constructed based on the patient's preoperative CT/MRI images, and a personalized physical model is created using 3D printing. This model has the ability to self-heal after being cut. Surgeons can perform multiple simulated surgeries on the model to plan the optimal surgical path before the authetic surgery

CT/MRI group

The surgical approach is planned based on traditional two-dimensional CT/MRI images, and the surgery is performed according to this planned path.

Group Type: SHAM_COMPARATOR

CT or MRI image

Intervention Type: OTHER

Obtain the patient's CT/MRI images and determine the definitive surgical path based on the two-dimensional images.

Interventions

3D printed models

A three-dimensional digital model is constructed based on the patient's preoperative CT/MRI images, and a personalized physical model is created using 3D printing. This model has the ability to self-heal after being cut. Surgeons can perform multiple simulated surgeries on the model to plan the optimal surgical path before the authetic surgery

Intervention Type: DEVICE

CT or MRI image

Obtain the patient's CT/MRI images and determine the definitive surgical path based on the two-dimensional images.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuhua Zhang, MD

Principal Investigator, Director of Hepatopancreatobiliary Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IRB-2025-27（IIT）

Identifier Type: -

Identifier Source: org_study_id