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NCT06911086Not yet recruitingPhase 2/3

SH-LPS System in Preoperative Planning for Liver Resection

SH-LPS System in Preoperative Planning for Liver Resection: a Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
100 (estimated)
First submitted
5 Mar 2025
Start date
15 Apr 2025
Primary completion date
1 Jan 2026
Lead sponsor
Zhejiang Cancer Hospital
NCT number
NCT06911086

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 100
  • From 15 Apr 2025 to the primary completion date, 1 Jan 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • There are other unsuitable candidates for clinical trials, such as mental illness or alcohol dependence.

Lab values

  • 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);

Other

  • Patients with extra-hepatic metastasis;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.