Health TrialsbyHealthPanel

SH-LPS System in Preoperative Planning for Liver Resection

ConditionsLiver Tumor; Surgery3D PrintingPreoperative Planning
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhejiang Cancer Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

18-80 years old;

Patients with a resectable tumor in the liver;

Eastern Cooperative Oncology Group Performance status score: 0;

Child-Pugh classification: A;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 3D groupExperimental treatment 1 intervention
Group B: CT/MRI groupSham comparator 1 intervention

Trial outcomes

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: