Hepatobiliary SurgeryNCT06526754
Feasibility Analysis of LCD-SLA 3D Printing Technology for Overall Surgical Planning of Liver Malignant Tumors
A study testing 3D-Printed Liver Model and Digital Simulation-Based Surgical Planning in people with Hepatobiliary Surgery and Liver Diseases, run by Yang Jihong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatobiliary Surgery, Liver Diseases
- What is being tested?
- 3D-Printed Liver Model and Digital Simulation-Based Surgical Planning
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hepatobiliary Surgery, Liver Diseases
- Being tested
- 3D-Printed Liver Model, Digital Simulation-Based Surgical Planning
- Keywords
- 3D Printing, Artificial Intelligence (AI), Deep Learning, Liver Model, Surgical Precision, Hepatobiliary Surgery, 3D Modeling, Randomized Controlled Trial, Medical Imaging, Digital Simulations
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Printed Liver ModelDevice
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 PlanningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 3D Printed Model Group (3DP) | Experimental | 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. Receives: Device: 3D-Printed Liver Model |
| 3D Virtual Model Group (3DV) | Experimental | 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. Receives: Procedure: Digital Simulation-Based Surgical Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the date of surgery until discharge, assessed up to 30 days.
Secondary outcomes (7)
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).
Measured: Before surgery
Sex
Record the sex of each patient in both the 3D Printed Model Group (3DP) and the 3D Virtual Model Group (3DV).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Jan 2019
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study involves three phases. Phase one focuses on developing and validating 3D-printed liver models. Phase two optimizes the 3D reconstruction process using AI-assisted segmentation. Phase three is a randomized controlled trial comparing surgical outcomes using physical 3D models versus digital simulations.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yang Jihong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Jihong, Affiliated Hospital of Hebei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526754
- Sponsor's protocol ID
- 2017Z001
- Status last verified
- Dec 2024
- First submitted
- 19 Jul 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Analysis of LCD-SLA 3D Printing Technology for Overall Surgical Planning of Liver Malignant Tumors
- ClinicalTrials.gov ID
- NCT06526754
- Acronym / sponsor ID
- 2017Z001
- Conditions
- Hepatobiliary Surgery, Liver Diseases
- Keywords
- 3D Printing, Artificial Intelligence (AI), Deep Learning, Liver Model, Surgical Precision, Hepatobiliary Surgery, 3D Modeling, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Yang JihongUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study involves three phases. Phase one focuses on developing and validating 3D-printed liver models. Phase two optimizes the 3D reconstruction process using AI-assisted segmentation. Phase three is a randomized controlled trial comparing surgical outcomes using physical 3D models versus digital simulations.
| Arm | Type | Receives |
|---|---|---|
| 3D Printed Model Group (3DP) | Experimental | Device: 3D-Printed Liver ModelParticipants 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. |
| 3D Virtual Model Group (3DV) | Experimental | Procedure: Digital Simulation-Based Surgical PlanningParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-Printed Liver ModelParticipants 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. | Device | 3D Printed Model Group (3DP) |
| Digital Simulation-Based Surgical PlanningParticipants 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. | Procedure or surgery | 3D Virtual Model Group (3DV) |
Primary outcome
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.
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.
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.
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.
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.
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.
7 secondary outcomes
Age
Time frame: Before surgery
Sex
Time frame: Before surgery
BMI (Body Mass Index)
Time frame: Before surgery
AFP (Alpha-Fetoprotein)
Time frame: Before surgery
Tumor Size
Time frame: During the surgery
Presence of Liver Cirrhosis
Time frame: Before surgery
HBV DNA Levels
Time frame: Before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Printed Liver Model and Digital Simulation-Based Surgical Planning in people with Hepatobiliary Surgery and Liver Diseases, run by Yang Jihong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Blood Loss (time frame: During the surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.