Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas (3D-HAPPI)

IHU Strasbourg

Status: Completed

Conditions: Hepatocarcinoma

Treatments: Procedure: Surgical planning

Study type: Interventional

Funder types: Other

Identifiers

NCT03382327

16-003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

136 participants in 1 patient group

Surgical planning

Experimental group

Description:

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.

Treatment:

Procedure: Surgical planning