Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas

Study Overview
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Brief Summary
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The aim of this study is to assess the benefit of 3D models in the planning of hepatic resection by comparing the changes in the surgical plan based on the analysis of conventional preoperative images (CT-scan and MRI), compared to the surgical plan based on the analysis of 3D reconstruction.

Detailed Description
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The detailed anatomical description of the liver described by Couinaud in 1954 is the basis for hepatic surgery. Surgical resection is the approach leading to the best survival rate in case of liver cancer. In hepatocarcinomas, systematic removal of the infected liver segment is considered the most effective technique to eliminate tumour, potential satellite nodules and avoid vascular spread. Resectability rate highly depends on the analysis of preoperative images. However, in 20% of cases, there are modifications compared with the initial surgical plan leading to an increase in morbidity rate. In 2002, Couinaud highlighted the difficulty of identifying portal pedicles, especially because of anatomical variations, and recommended the use of a three-dimensional reconstruction from images provided by a helical scanner. The hypothesis of the study is that 3D models would improve surgical planning leading to a decrease in intra-operative adjustments and mortality. The aim of this multicentric, prospective study is to assess the benefit of 3D models in the surgical management of hepatocarcinomas, more specifically in the detailed analysis of 3D vascular structures and in the surgery planning with resection merges evaluation. The validation of this virtual method will be built on the comparison of the surgical plan based on the analysis of conventional preoperative images (CT-scan and MRI) and the surgical plan based on the analysis of 3D reconstruction.

Official Title
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Multicentric Study Determining the Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas

Conditions
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Hepatocarcinoma

Intervention / Treatment
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* Procedure: Surgical planning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a hepatocarcinoma, eligible for surgical resection Patient over 18 years old Patient able to understand the study and provide written informed consent Patient affiliated to the French social security system. Exclusion Criteria: Patient with other liver tumours Patient whose general condition is not suitable for study participation (WHO ≥ 3) Patient with a condition preventing its participation to study procedures, according to investigator's judgment Patient with contraindications to injected CT-scan or MRI: allergic reaction to contrast agents, kidney failure, pacemaker, claustrophobia Pregnancy or breastfeeding Patient in exclusion period (determined by a previous study or in progress) Patient in custody Patient under guardianship.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical planning<br>Two surgical plans will be established preoperatively. The first plan will be based on standard preoperative images (CT-scan, MRI) review. The second plan will be based on the 3D model review. | Procedure: Surgical planning<br>* Two surgical plans will be established preoperatively. The first plan will be based on standard preoperative images (CT-scan, MRI) review. The second plan will be based on the 3D model review. Both will be compared to the actual surgery performed in the operating room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the intra-operative modifications rates | Modifications in the surgical planning compared to the plan based on the analysis of standard preoperative images (CT-scan and MRI) and the plan based on the 3D model analysis: changes in surgical resection type (by specifying the surgical act: tumorectomy, segmentectomy, bi-segmentectomy or lobectomy…) or no surgery. | At time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of tumor(s) location | Comparison of tumor(s) location based on 3D model and standard preoperative images analysis. | At time of surgery | 
| Comparison of vascular network anatomy | Comparison of vascular network anatomy based on 3D model and standard preoperative images analysis. | At time of surgery | 
| Choice of surgical plan | Surgery done according to a) surgical plan based on standard preoperative images analysis, b) surgical plan based on 3D model analysis or c) alternative approach (by specifying the surgical act: tumorectomy, segmentectomy, bi-segmentectomy or lobectomy….) | At time of surgery | 
| Modification of the initial surgical plan, if applicable | Description of perioperative events having modified the initial surgical plan. | At time of surgery | 
| Comparison of resection merges | Comparison of expected resection merges based on standard preoperative images and 3D model analysis and actual resection merge in the operating room. | At time of surgery | 
| Comparison of resection volumes | Comparison of expected resection volumes based on standard preoperative images and 3D model analysis and actual resection volume in the operating room. | At time of surgery | 
| Comparison of surgical merge size | Comparison of surgical merge size (mm) based on 3D model and standard preoperative images analysis. | At time of surgery | 
| Morbidity | Morbidity specific to the procedure. | At time of surgery and 3 months after surgery | 
| Mortality | Mortality specific to the procedure. | At time of surgery and 3 months after surgery | 
| Preoperative images independent analysis | Analysis of preoperative images (CT-scan/MRI and 3D model) by a senior team on one hand, and a junior team (surgeons + radiologists) on the other hand. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical planning, CT-scan, MRI, 3D model, Hepatocarcinoma eligible for surgical resection