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

Hepatocarcinoma Clinical Trial

— 3D-HAPPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382327
• Other study ID #: 16-003
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: October 16, 2020

Study information

• Verified date: February 2021
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: October 16, 2020
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocarcinoma

Intervention

Procedure:
• Surgical planning
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.

Locations

Country	Name	City	State
France	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	Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil	Strasbourg
France	Centre Hépato-Biliaire - Hôpital Paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (4)

Couinaud C. [Errors in the topographic diagnosis of liver diseases]. Ann Chir. 2002 Jun;127(6):418-30. Review. French. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of tumor(s) location	Comparison of tumor(s) location based on 3D model and standard preoperative images analysis.	At time of surgery
Secondary	Comparison of vascular network anatomy	Comparison of vascular network anatomy based on 3D model and standard preoperative images analysis.	At time of surgery
Secondary	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
Secondary	Modification of the initial surgical plan, if applicable	Description of perioperative events having modified the initial surgical plan.	At time of surgery
Secondary	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
Secondary	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
Secondary	Comparison of surgical merge size	Comparison of surgical merge size (mm) based on 3D model and standard preoperative images analysis.	At time of surgery
Secondary	Morbidity	Morbidity specific to the procedure.	At time of surgery and 3 months after surgery
Secondary	Mortality	Mortality specific to the procedure.	At time of surgery and 3 months after surgery
Secondary	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