Revolutionizing Hepatobiliary Surgical Planning: Deep Learning-Enhanced 3D Printing Versus Traditional Digital Simulations
NCT Number: NCT06526754
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hepatobiliary Surgery|Liver Diseases
Interventions: DEVICE: 3D-Printed Liver Model|PROCEDURE: Digital Simulation-Based Surgical Planning
Sponsor: Li Linqian
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-01-01
Completion Date: 2024-01-01
Locations: Affiliated Hospital of Hebei University, Baoding, Hebei, 071000, China

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.

Primary Outcome Measures: 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: 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