Feasibility Analysis of LCD-SLA 3D Printing Technology for Overall Surgical Planning of Liver Mal… (NCT06526754) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Analysis of LCD-SLA 3D Printing Technology for Overall Surgical Planning of Liver Malignant Tumors
China64 participantsStarted 2019-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraoperative Blood Loss
Timeframe: During the surgery
2
Blood Transfusion
Timeframe: During the surgery
3
Operation Duration
Timeframe: During the surgery
4
Surgical Margin Status
Timeframe: Immediately after surgery
5
Postoperative Hospital Stay
Timeframe: From surgery to discharge
6
Postoperative Complications
Timeframe: From the date of surgery until discharge, assessed up to 30 days.