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Completed

NCT Number: NCT06526754

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Hebei University

Baoding, Hebei, 071000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D-Printed Liver Model

Device

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.

Digital Simulation-Based Surgical Planning

Procedure

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.

Primary outcomes

  1. Intraoperative Blood Loss

    Time frame: 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.

  2. Blood Transfusion

    Time frame: 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.

  3. Operation Duration

    Time frame: 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.

  4. Surgical Margin Status

    Time frame: 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.

  5. Postoperative Hospital Stay

    Time frame: 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.

  6. Postoperative Complications

    Time frame: 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.

Secondary outcomes

  1. Age

    Time frame: Before surgery

    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).

  2. Sex

    Time frame: Before surgery

    Record the sex of each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV).

  3. BMI (Body Mass Index)

    Time frame: Before surgery

    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).

  4. AFP (Alpha-Fetoprotein)

    Time frame: Before surgery

    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.

  5. Tumor Size

    Time frame: During the surgery

    Measure the size of the tumor in each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV).

  6. Presence of Liver Cirrhosis

    Time frame: Before surgery

    Record whether each patient has liver cirrhosis in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV).

  7. HBV DNA Levels

    Time frame: Before surgery

    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.

Sponsors and collaborators

Lead sponsor

Yang Jihong

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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