NCT06006338

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-15
• Primary completion: 2023-12-31
• Completion: 2024-02-29
• First posted: 2023-08-23
• Last updated: 2023-09-21

Locations

1 site across 1 country: China