3D Printing, Liver Tumor; Surgery, Preoperative Planning
Conditions
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.
Interventions
DEVICE3D 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
OTHERCT or MRI image
Obtain the patient's CT/MRI images and determine the definitive surgical path based on the two-dimensional images.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | Until three months after the surgery | The incidence rate of surgical complications |
| 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 |
| 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. |
Outcome results
None listed