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NCT Number: NCT06911086

SH-LPS System in Preoperative Planning for Liver Resection

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.

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Key information

Conditions

Liver Tumor; Surgery 3D Printing Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Preoperative Planning

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

CT or MRI image

Other

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

Primary outcomes

  1. Opertation duration

    Time frame: Until the end of the surgey

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

  2. Blood loss

    Time frame: Until the end of the surgey

    Blood loss during the operation

Secondary outcomes

  1. R0 resection rate

    Time frame: 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

  2. Surgical complications

    Time frame: Until three months after the surgery

    The incidence rate of surgical complications

  3. Postoperative hospital stay.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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