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

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Hepatobiliary Surgery
• Intervention / Treatment: Device: 3D-Printed Liver Model; Procedure: Digital Simulation-Based Surgical Planning

Detailed Description

The study was conducted in three phases to assess the effectiveness of 3D-printed liver models for hepatobiliary surgery planning, comparing these models with traditional digital simulations.

Phase One: This phase involved the development and validation of 35 3D-printed liver models. The focus was on timeliness, cost, precision, and alignment with digital planning tools. The goal was to ensure that the physical models accurately represented the liver's anatomy as planned digitally.

Phase Two: In this phase, the 3D reconstruction process was optimized using deep learning techniques. The study compared AI-assisted automatic segmentation with manual methods to enhance the accuracy and efficiency of the models. This phase aimed to streamline the model creation process and reduce the time and effort required.

Phase Three: This phase conducted a retrospective comparative analysis involving 64 patients who underwent hepatobiliary surgery. These patients were divided into two groups: one group used validated physical 3D models, and the other group used digital simulations for surgical planning. The phase evaluated various surgical outcomes, including the extent of resection, operation time, intraoperative blood loss, and hospitalization duration. The primary objective was to determine the clinical effectiveness of using 3D-printed models compared to traditional digital simulations in hepatobiliary surgery planning.

By systematically analyzing these three phases, the study aims to provide comprehensive insights into the benefits and potential limitations of using 3D-printed models in surgical planning, ultimately enhancing patient outcomes and surgical precision.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Baoding, Hebei, China, 071000
      • Affiliated Hospital of Hebei University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age: Patients aged 18-75 years
• Gender: Both male and female patients
• Diagnosis: Confirmed diagnosis of hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (iCCA), or perihilar cholangiocarcinoma (pCCA)
• Surgical Candidates: Patients who are candidates for hepatectomy
• Liver Function: Patients with adequate liver function (Child-Pugh A or B)
• Informed Consent: Patients who provide written informed consent

Exclusion Criteria:

• Non-Surgical Candidates: Patients not eligible for surgery due to advanced disease or comorbidities
• Pregnancy: Pregnant or breastfeeding women
• Severe Comorbidities: Patients with severe cardiovascular, respiratory, renal, or other systemic diseases
• Previous Liver Surgery: Patients with a history of previous liver resection or transplantation
• Uncontrolled Infections: Patients with uncontrolled active infections
• Inability to Comply: Patients unable to comply with study procedures or follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D Printed Model Group (3DP); Participants in this group will receive surgical planning based on physically developed and validated 3D-printed liver models from Phase One. The surgical procedures will be guided by these 3D-printed models.	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.
Experimental: 3D Virtual Model Group (3DV); Participants in this group will receive surgical planning based on digital simulations using the fastest AI-assisted segmentation method with manual adjustments from Phase Two. The surgical procedures will be guided by these digital simulations.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Blood Loss	Measure the volume of blood loss during surgery for each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV). This outcome assesses the efficacy of using 3D-printed liver models in reducing intraoperative blood loss compared to digital simulations.	During the surgery
Blood Transfusion	Assess the need for intraoperative blood transfusions for each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV). This outcome evaluates the impact of using 3D-printed liver models on the necessity for transfusions.	During the surgery
Operation Duration	Measure the total duration of the surgical procedure for each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV). This outcome assesses whether the use of 3D-printed models can reduce operation time.	During the surgery
Surgical Margin Status	Assess the status of surgical margins post-resection to determine the precision of tumor removal in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV). R0 indicates no residual tumor, R1 indicates microscopic residual tumor.	Immediately after surgery
Postoperative Hospital Stay	Measure the length of hospital stay post-surgery for each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV). This outcome evaluates the impact of 3D-printed models on postoperative recovery time.	From surgery to discharge
Postoperative Complications	Measure the length of hospital stay post-surgery for each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV). This outcome evaluates the impact of 3D-printed models on postoperative recovery time.	From the date of surgery until discharge, assessed up to 30 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Document the age of each patient at the time of surgery in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV).	Before surgery
Sex	Record the sex of each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV).	Before surgery
BMI (Body Mass Index)	Measure and record the Body Mass Index (BMI) of each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV).	Before surgery
AFP (Alpha-Fetoprotein)	Measure the levels of Alpha-Fetoprotein (AFP) in the blood of each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV) to assess liver cancer biomarkers.	Before surgery
Tumor Size	Measure the size of the tumor in each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV).	During the surgery
Presence of Liver Cirrhosis	Record whether each patient has liver cirrhosis in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV).	Before surgery
HBV DNA Levels	Measure the levels of HBV DNA in the blood of each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV) to assess the presence and extent of hepatitis B infection.	Before surgery

Collaborators and Investigators

• Sponsor: Yang Jihong

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; 3D Modeling; 3D Printing; Deep Learning; Artificial Intelligence (AI); Medical Imaging; Hepatobiliary Surgery; Liver Model; Surgical Precision; Digital Simulations
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Neoplasms; Liver Diseases
• Other Study ID Numbers: 2017Z001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The plan includes sharing deidentified individual participant data (IPD) including study protocol, statistical analysis plan (SAP), informed consent form (ICF), clinical study report (CSR), and analytic code.
• IPD Sharing Time Frame: The data will be available starting 6 months after the publication and will be accessible for 5 years.
• IPD Sharing Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Proposals should be directed to [lilinqian163@163.com]. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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