Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06911086

Not yet recruiting

SH-LPS System in Preoperative Planning for Liver Resection

Interventional

Phase 2/3

Sponsor: Zhejiang Cancer Hospital

Last Updated: April 4, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Treatment Category

Device, Other

Required Mutations

None

Trial Started

April 15, 2025

Last Updated by Sponsor

April 4, 2025

Estimated Completion

January 1, 2026

Contact Study

Eligibility

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.

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Design Details

AllocationRandomized

Intervention ModelParallel Assignment

MaskingSingle

Number to Enroll100

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: 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.

Interventions:

3D printed models
CT or MRI image

Outcome Measures

Primary Outcome Measures

Opertation durationUntil the end of the surgey

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

Blood lossUntil the end of the surgey

Blood loss during the operation

Secondary Outcome Measures

R0 resection rateUntil 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 complicationsUntil 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.