Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

Study Overview
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Brief Summary
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To explore the utility of personalized 3D printed liver models in planning and navigating laparoscopic resections.

Detailed Description
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Project goal is to evaluate utility of personalized 3D printed models in preoperative planning and performing laparoscopic liver resections. Models will be developed with unique, low-cost approach. Project will consist of three overlapping modules/stages evaluating: Accuracy of 3D printed liver models compared to computed tomography and standard surface or volume rendering Whether 3D printed utilized in planning surgery affects the decision making regarding the surgical plan Whether 3D printed models utilized in planning and navigating laparoscopic resections affect perioperative outcomes Methodology of developing 3D models is described elsewhere. Printed models will be delivered to surgical team at least 5 days prior to the resection. Surgery will be performed in both arms according to the department's procedures and surgical oncology guidelines.

Official Title
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Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

Conditions
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Liver Cancer, Hepatocellular Carcinoma, Liver Metastases

Intervention / Treatment
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* Procedure: Laparoscopic liver resection
* Device: 3D printing model


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 Patient qualified to undergo liver tumor resection (either primary of metastatic; both benign and malignant lesions) Quality of imaging (CT or MRI or PET (positron emission tomography)/CT) satisfactory to develop 3D models Laparoscopic approach Informed consent Exclusion Criteria: Open approach Technical limitations to model development No informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With 3D Model<br>Patients in this arm will undergo laparoscopic liver resection with prior planning utilizing both 3D printed model and computed tomography (or/and magnetic resonance imaging) | Procedure: Laparoscopic liver resection<br>* Laparoscopic liver resection for oncological purposes<br>Device: 3D printing model<br>* Use of 3D printed liver model in decision-making: preoperative planning and intraoperative guidance.<br>|
| Active Comparator: Without 3D Model<br>Patients in this arm will undergo laparoscopic liver resection with prior planning utilizing only standard medical imaging computed tomography (or/and magnetic resonance imaging) without development of 3D printed model | Procedure: Laparoscopic liver resection<br>* Laparoscopic liver resection for oncological purposes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of changes in surgery plan |  | intraoperative | 
| Blood loss |  | intraoperative | 
| Operative time |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Number of both total and severe (Clavien-Dindo>=3) complications | intraoperative and until discharge, an average of 7 days | 
| Length of stay |  | until patient discharge, an average of 7 days | 
| Conversion rate |  | intraoperative | 
| Readmissions |  | 6 months | 
| Mortality |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D printing, Liver cancer, Laparoscopic surgery