3D Printed Models for Liver Surgery

Phase 1

Recruiting

• Conditions: Liver Cancer
• Interventions: Other: 3D Printed Model for preoperative planning

• Registration Number: NCT06006338
• Lead Sponsor: Zhejiang Cancer Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-23
• Status Verified: 2023-09
• Study Start: 2023-09-15
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	3D Printed Model for preoperative planning	-

Primary Outcome Measures

Name	Time	Method
R0 resection rate	10 days	The proportion of patients who achieved pathological negative surgical margin

Secondary Outcome Measures

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

Trial Locations

Locations (1)

1# Banshan East Rd. Zhejiang cancer hospital; 🇨🇳 Hangzhou, Zhejiang, China