Clinical trial NCT06911086: SH-LPS System in Preoperative Planning for Liver Resection
Official title: SH-LPS System in Preoperative Planning for Liver Resection: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Liver Tumor; Surgery
3D Printing
Preoperative Planning
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Opertation duration
timeFrame: Until the end of the surgey
measure: Blood loss
timeFrame: Until the end of the surgey
Secondary outcomes:
measure: R0 resection rate
timeFrame: Until the day the official pathology report comes out, an average of two weeks
measure: Surgical complications
timeFrame: Until three months after the surgery
measure: Postoperative hospital stay.
timeFrame: Until the day the patient is discharged, an average of one week.
Other outcomes:
Locations:
Study officials:
References: