SH-LPS System in Preoperative Planning for Liver Resection

NCT06911086 | Not Yet Recruiting Phase 2

• 1 other identifier: IRB-2025-27（IIT）
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Opertation duration

  The duration from the start to the end of the surgery.

  Until the end of the surgey

• Blood loss

  Blood loss during the operation

  Until the end of the surgey

Secondary Outcomes (3)

• R0 resection rate

  Until the day the official pathology report comes out, an average of two weeks

• Surgical complications

  Until three months after the surgery

• Postoperative hospital stay.

  Until the day the patient is discharged, an average of one week.

Study Arms (2)

3D group

EXPERIMENTAL

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.

Device: 3D printed models

CT/MRI group

SHAM COMPARATOR

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

Other: CT or MRI image

Interventions

3D printed models 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

3D group

CT or MRI image OTHER

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

CT/MRI group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of Hepatopancreatobiliary Surgery

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: April 4, 2025
• Study Start: April 15, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share