Using 3D printed liver models to improve liver cancer surgery
The Clinical Value of 3D Self-healing Elastic Liver Model for Surgical Training and Preoperative Planning: a Preliminary Study
This study is testing whether using 3D printed liver models can help doctors plan and perform safer and more effective surgeries for people with liver cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06006338 on ClinicalTrials.gov |
What this trial studies
This clinical trial explores the use of innovative 3D printed liver models to enhance preoperative planning and intraoperative guidance for liver cancer surgeries. The models are made from a self-healing elastomer that can quickly restore its structure after being cut, allowing for iterative testing of surgical approaches. The goal is to determine if these models can improve the safety and effectiveness of liver resections when combined with traditional imaging methods like CT or MRI.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 with a resectable liver tumor and good overall health.
Not a fit: Patients with extra-hepatic metastasis or those who have undergone recent anti-cancer therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more precise liver cancer surgeries, improving patient outcomes.
How similar studies have performed: While the use of 3D printed models in surgery is an emerging field, similar studies have shown promising results in other types of surgeries, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- 1# Banshan East Rd. Zhejiang cancer hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Chaoqun Fei
- Email: ec@zjcc.org.cn
- Phone: +086-0571-88122564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.