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

Not Applicable

Completed

• Conditions: Hepatocarcinoma

• Registration Number: NCT03382327
• Lead Sponsor: IHU Strasbourg

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-10-16
• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-22
• Primary Completion: 2020-10-16
• Study Completion: 2020-10-16
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Comparison of the intra-operative modifications rates	At time of surgery	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.

Secondary Outcome Measures

Name	Time	Method
Morbidity	At time of surgery and 3 months after surgery	Morbidity specific to the procedure.
Comparison of tumor(s) location	At time of surgery	Comparison of tumor(s) location based on 3D model and standard preoperative images analysis.
Comparison of surgical merge size	At time of surgery	Comparison of surgical merge size (mm) based on 3D model and standard preoperative images analysis.
Mortality	At time of surgery and 3 months after surgery	Mortality specific to the procedure.
Comparison of vascular network anatomy	At time of surgery	Comparison of vascular network anatomy based on 3D model and standard preoperative images analysis.
Comparison of resection merges	At time of surgery	Comparison of expected resection merges based on standard preoperative images and 3D model analysis and actual resection merge in the operating room.
Choice of surgical plan	At time of surgery	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....)
Modification of the initial surgical plan, if applicable	At time of surgery	Description of perioperative events having modified the initial surgical plan.
Comparison of resection volumes	At time of surgery	Comparison of expected resection volumes based on standard preoperative images and 3D model analysis and actual resection volume in the operating room.
Preoperative images independent analysis	3 years	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.

Trial Locations

Locations (12)

Service de Chirurgie Digestive - Hôpital Beaujon; 🇫🇷 Clichy, France

Hôpital Henri Mondor - Service de Chirurgie Digestive et Hépatobiliaire -; 🇫🇷 Créteil, France

Service de Chirurgie Digestive et Transplantation - Hôpital Claude Huriez; 🇫🇷 Lille, France

Service de Chirurgie Digestive et Transplantation Hépatique - Hôpital universitaire de la Croix-Rousse; 🇫🇷 Lyon, France

Service de Chirurgie Digestive - CH Emile Muller; 🇫🇷 Mulhouse, France

Chirurgie Viscérale et Digestive - Polyclinique de Gentilly; 🇫🇷 Nancy, France

Chirurgie Digestive, Hépato-bilio-pancréatique et Transplantation - La Pitié Sâlpêtrière; 🇫🇷 Paris, France

Service de Chirurgie Digestive - CHU Robert Debré; 🇫🇷 Reims, France

Service de Chirurgie Digestive Hôpital Charles Nicolle - CHU Rouen; 🇫🇷 Rouen, France

Institut de Chirurgie Viscérale - Clinique de l'Orangerie; 🇫🇷 Strasbourg, France

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