Revolutionizing Hepatobiliary Surgical Planning: A Randomized Comparative Analysis of Deep Learning-Enhanced 3D Printing Versus Traditional Digital Simulations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Intraoperative Blood Loss
研究概览
简要总结
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:
- Development and validation of 35 3D-printed liver models, focusing on timeliness, cost, precision, and alignment with digital planning tools.
- Optimization of the 3D reconstruction process using deep learning to enhance model accuracy and efficiency.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
he random allocation sequence was implemented using sequentially numbered, opaque sealed envelopes, each containing a card indicating group assignment. An independent administrative staff member, not involved in enrollment or treatment, prepared the envelopes. To conceal the allocation sequence, envelopes were stored in a secure, locked cabinet accessible only to the study coordinator, who was not involved in patient evaluations or surgeries. This maintained clinician blindness to allocations, preserving the integrity of the randomization process. Third-party medical staff, blinded to group allocation, evaluated the outcomes to ensure objective assessment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Intraoperative Blood Loss
时间窗: During the surgery
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.
Blood Transfusion
时间窗: During the surgery
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.
Surgical Margin Status
时间窗: Immediately after surgery
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.
Operation Duration
时间窗: During the surgery
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.
Postoperative Hospital Stay
时间窗: From surgery to discharge
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.
Postoperative Complications
时间窗: From the date of surgery until discharge, assessed up to 30 days.
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.
次要结局
- Tumor Size(During the surgery)
- HBV DNA Levels(Before surgery)
- Age(Before surgery)
- BMI (Body Mass Index)(Before surgery)
- AFP (Alpha-Fetoprotein)(Before surgery)
- Sex(Before surgery)
- Presence of Liver Cirrhosis(Before surgery)
研究者
Li Linqian
physician
Affiliated Hospital of Hebei University