Clinical trial NCT03382327: Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas
Official title: Multicentric Study Determining the Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocarcinoma
Keywords: Surgical planning
CT-scan
MRI
3D model
Hepatocarcinoma eligible for surgical resection
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the intra-operative modifications rates
timeFrame: At time of surgery
Secondary outcomes:
measure: Comparison of tumor(s) location
timeFrame: At time of surgery
measure: Comparison of vascular network anatomy
timeFrame: At time of surgery
measure: Choice of surgical plan
timeFrame: At time of surgery
measure: Modification of the initial surgical plan, if applicable
timeFrame: At time of surgery
measure: Comparison of resection merges
timeFrame: At time of surgery
measure: Comparison of resection volumes
timeFrame: At time of surgery
measure: Comparison of surgical merge size
timeFrame: At time of surgery
measure: Morbidity
timeFrame: At time of surgery and 3 months after surgery
measure: Mortality
timeFrame: At time of surgery and 3 months after surgery
measure: Preoperative images independent analysis
timeFrame: 3 years
Other outcomes:
Locations:
city: Clichy
country: France
facility: Service de Chirurgie Digestive - Hôpital Beaujon
city: Créteil
country: France
facility: Hôpital Henri Mondor - Service de Chirurgie Digestive et Hépatobiliaire -
city: Lille
country: France
facility: Service de Chirurgie Digestive et Transplantation - Hôpital Claude Huriez
city: Lyon
country: France
facility: Service de Chirurgie Digestive et Transplantation Hépatique - Hôpital universitaire de la Croix-Rousse
city: Mulhouse
country: France
facility: Service de Chirurgie Digestive - CH Emile Muller
city: Nancy
country: France
facility: Chirurgie Viscérale et Digestive - Polyclinique de Gentilly
city: Paris
country: France
facility: Chirurgie Digestive, Hépato-bilio-pancréatique et Transplantation - La Pitié Sâlpêtrière
city: Reims
country: France
facility: Service de Chirurgie Digestive - CHU Robert Debré
city: Rouen
country: France
facility: Service de Chirurgie Digestive Hôpital Charles Nicolle - CHU Rouen
city: Strasbourg
country: France
facility: Institut de Chirurgie Viscérale - Clinique de l'Orangerie
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
city: Villejuif
country: France
facility: Centre Hépato-Biliaire - Hôpital Paul Brousse
Study officials:
affiliation: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
name: Patrick Pessaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gauss T, Merckx P, Brasher C, Kavafyan J, Le Bihan E, Aussilhou B, Belghiti J, Mantz J. Deviation from a preoperative surgical and anaesthetic care plan is associated with increased risk of adverse intraoperative events in major abdominal surgery. Langenbecks Arch Surg. 2013 Feb;398(2):277-85. doi: 10.1007/s00423-012-1028-3. Epub 2012 Nov 13.
citation: Couinaud C. [Errors in the topographic diagnosis of liver diseases]. Ann Chir. 2002 Jun;127(6):418-30. doi: 10.1016/s0003-3944(02)00802-7. French.
citation: Mutter D, Dallemagne B, Bailey Ch, Soler L, Marescaux J. 3D virtual reality and selective vascular control for laparoscopic left hepatic lobectomy. Surg Endosc. 2009 Feb;23(2):432-5. doi: 10.1007/s00464-008-9931-y. Epub 2008 Apr 29.
citation: Mutter D, Soler L, Marescaux J. Recent advances in liver imaging. Expert Rev Gastroenterol Hepatol. 2010 Oct;4(5):613-21. doi: 10.1586/egh.10.57.