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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Other: 3D Printed Model for preoperative planning

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chaoqun Fei; Phone Number: +086-0571-88122564; Email: ec@zjcc.org.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • 1# Banshan East Rd. Zhejiang cancer hospital
      • Contact: Yuhua Zhang, M.D.; Phone Number: +86-0571-88128058; Email: drzhangyuhua@126.com
      • Contact: Xing Chen; Phone Number: +86-19858152505; Email: chenxing@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental arm

Other: 3D Printed Model for preoperative planning; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 resection rate	The proportion of patients who achieved pathological negative surgical margin	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injury of vital vascular structures	The Injury of vital vascular structures, such as portal veins or hepatic veins.	Immediately after the surgery.
Operation time	Time length (minute) between the beginning and the end of the surgery.	Immediately after the surgery.
Blood loss	The amount of lost blood (ml) in the operation.	Immediately after the surgery.

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Study Chair: Yuhua Zhang, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: ZYH-CX-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No