Hepatocellular Carcinoma, Liver Cancer, Liver Metastases
Conditions
Keywords
3D printing, Liver cancer, Laparoscopic surgery
Brief summary
To explore the utility of personalized 3D printed liver models in planning and navigating laparoscopic resections.
Detailed description
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: 1. Accuracy of 3D printed liver models compared to computed tomography and standard surface or volume rendering 2. Whether 3D printed utilized in planning surgery affects the decision making regarding the surgical plan 3. 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.
Interventions
PROCEDURELaparoscopic liver resection
Laparoscopic liver resection for oncological purposes
DEVICE3D printing model
Use of 3D printed liver model in decision-making: preoperative planning and intraoperative guidance.
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of changes in surgery plan | intraoperative |
| Blood loss | intraoperative |
| Operative time | intraoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Readmissions | 6 months | — |
| Complications | intraoperative and until discharge, an average of 7 days | Number of both total and severe (Clavien-Dindo\>=3) complications |
| Mortality | 90 days | — |
| Length of stay | until patient discharge, an average of 7 days | — |
| Conversion rate | intraoperative | — |
Countries
Poland
Outcome results
None listed