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Not yet recruitingNCT06911086Updated Apr 4, 2025

SH-LPS System in Preoperative Planning for Liver Resection

A Phase 2/3 interventional study of 3D printed models and CT or MRI image in Liver Tumor; Surgery, 3D Printing and Preoperative Planning, sponsored by Zhejiang Cancer Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Zhejiang Cancer Hospital · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

02

Conditions studied

  • Liver Tumor; Surgery
  • 3D Printing
  • Preoperative Planning
03

In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 100 is above the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 281 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    3D group

    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.

    Device: 3D printed models

  • Sham comparator
    CT/MRI group

    The surgical approach is planned based on traditional two-dimensional CT/MRI images, and the surgery is performed according to this planned path.

    Other: CT or MRI image

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.

06

What researchers measure

Primary outcomes

  1. Opertation duration

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

    Time frame: Until the end of the surgey

  2. Blood loss

    Blood loss during the operation

    Time frame: Until the end of the surgey

Secondary outcomes

  1. R0 resection rate

    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

    Time frame: Until the day the official pathology report comes out, an average of two weeks

  2. Surgical complications

    The incidence rate of surgical complications

    Time frame: Until three months after the surgery

  3. Postoperative hospital stay.

    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.

    Time frame: Until the day the patient is discharged, an average of one week.

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06911086
Responsible party
Yuhua Zhang, MD (Principal Investigator, Director of Hepatopancreatobiliary Surgery, Zhejiang Cancer Hospital) — Principal investigator
First posted
Apr 4, 2025
Start date
Apr 15, 2025 (estimated)
Primary completion
Jan 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Apr 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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