Feasibility Analysis of LCD-SLA 3D Printing Technology for Overall Surgical Planning of Liver Malignant Tumors

NCT06526754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-12-18

No results posted yet for this study

Summary

This study aims to evaluate the effectiveness of 3D-printed liver models in hepatobiliary surgery planning compared to traditional digital simulations. It is conducted in three phases:

1. Development and validation of 35 3D-printed liver models, focusing on timeliness, cost, precision, and alignment with digital planning tools.
2. Optimization of the 3D reconstruction process using deep learning to enhance model accuracy and efficiency.
3. A retrospective comparative analysis of surgical outcomes in 64 patients, with one group using 3D-printed models and the other using digital simulations for surgical planning.

Conditions

Interventions

DEVICE

3D-Printed Liver Model

Participants in the 3D Printed Model Group (3DP) will receive surgical planning based on physically developed and validated 3D-printed liver models from Phase One. These models will be used to guide the surgical procedures.

PROCEDURE

Digital Simulation-Based Surgical Planning

Participants in the 3D Virtual Model Group (3DV) will receive surgical planning based on digital simulations using the fastest AI-assisted segmentation method with manual adjustments from Phase Two. These digital simulations will be used to guide the surgical procedures.

Sponsors & Collaborators

  • Yang Jihong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2024-01-01
Completion
2024-01-01

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06526754 on ClinicalTrials.gov