3D Printed Models for Liver Surgery

Trial Title: 3D Printed Models for Liver Surgery

NCT ID: NCT06006338

Condition: Liver Cancer

Conditions: Official terms:
Liver Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Device Feasibility

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: 3D Printed Model for preoperative planning
Description: Besides conventional preoperative planning based on contrast-enhanced CT/MRI, the investigator refers to a 3D printed model to determine the optimal surgical approach via a trial-and-error method. Specifically, a personalized 3D printed model is fabricated. By referring to the printed model and CT/MRI images, a preliminary surgical trace is determined. Then, a simulation surgery is performed on the model, and surgical margin and the potential injury of vital vascular structures are evaluated. This assessment leads to the adjustment of the surgical path as necessary. The refined surgical route is then validated through a second simulation surgery performed on the healed 3D model. This iterative process is repeated multiple times, allowing for a comprehensive exploration of various approaches until the optimal surgical strategy crystallizes. Next, the investigator proceeds to execute the real surgery on the participant, meticulously adhering to the determined optimal surgical approach.
Arm group label: Experimental arm

Summary: 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.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: 1# Banshan East Rd. Zhejiang cancer hospital

Address:
City: Hangzhou
Zip: 310022
Country: China

Status: Recruiting

Contact:
Last name: Yuhua Zhang, M.D.

Phone: +86-0571-88128058
Email: drzhangyuhua@126.com

Contact backup:
Last name: Xing Chen

Phone: +86-19858152505
Email: chenxing@zjcc.org.cn

Start date: September 15, 2023

Completion date: February 29, 2024

Lead sponsor:
Agency: Zhejiang Cancer Hospital
Agency class: Other

Source: Zhejiang Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06006338