Clinical trial · Interventional
3D Printed Models for Liver Surgery
The Clinical Value of 3D Self-healing Elastic Liver Model for Surgical Training and Preoperative Planning: a Preliminary Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Comprehensive preoperative planning and real-time intraoperative guidance are essential prerequisites for achieving precise liver resection. In pursuit of this goal, the investigators have developed innovative 3D printed liver models utilizing a physically crosslinked self-healing elastomer created through the copolymerization of 4-acryloylmorpholine (ACMO) and methoxy poly (ethylene glycol) acrylate (mPEGA). These printed models exhibit exceptional healing capabilities, efficiently restoring their structure within minutes at room temperature, and rapidly recovering within moments after being incised. Herein, the investigators aim to assess the viability of employing these 3D printed liver models as instrumental tools in designing the optimal surgical approach through an iterative trial-and-error methodology. Concurrently, the investigators aim to determine whether the integration of these 3D printed models into conventional methods (contrast-enhanced CT or MRI) can enhance the safety, ease, and efficiency of hepatic resection procedures.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D Printed Model for preoperative planning | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- interventionNames
- Other: 3D Printed Model for preoperative planning
Primary outcomes (1)
- measure
- R0 resection rate
- timeFrame
- 10 days
- description
- The proportion of patients who achieved pathological negative surgical margin
Secondary outcomes (3)
- measure
- Injury of vital vascular structures
- timeFrame
- Immediately after the surgery.
- description
- The Injury of vital vascular structures, such as portal veins or hepatic veins.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18-80 years old; 2. Patients with a resectable tumor in the liver; 3. Eastern Cooperative Oncology Group Performance status score: 0; 4. Child-Pugh classification: A; 5. 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 Prothrombin time(PT)exceed ULN≤6s, Creatinine clearance≥60 mL/min. Exclusion Criteria: 1. Patients with extra-hepatic metastasis; 2. Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation in 28 days prior to the surgery; 3. Clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy; 4. 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); 5. There are other unsuitable candidates for clinical trials, such as mental illness or alcohol dependence.
References
Publications (1)
- DERIVEDLu Y, Chen X, Han F, Zhao Q, Xie T, Wu J, Zhang Y. 3D printing of self-healing personalized liver models for surgical training and preoperative planning. Nat Commun. 2023 Dec 19;14(1):8447. doi: 10.1038/s41467-023-44324-6. PMID 38114507