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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatocarcinoma
• Intervention / Treatment: Procedure: Surgical planning

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 Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clichy, France, 92112
    • Service de Chirurgie Digestive - Hôpital Beaujon
  • Créteil, France, 94010
    • Hôpital Henri Mondor - Service de Chirurgie Digestive et Hépatobiliaire -
  • Lille, France, 59037
    • Service de Chirurgie Digestive et Transplantation - Hôpital Claude Huriez
  • Lyon, France, 69317
    • Service de Chirurgie Digestive et Transplantation Hépatique - Hôpital universitaire de la Croix-Rousse
  • Mulhouse, France, 68100
    • Service de Chirurgie Digestive - CH Emile Muller
  • Nancy, France, 54100
    • Chirurgie Viscérale et Digestive - Polyclinique de Gentilly
  • Paris, France, 75013
    • Chirurgie Digestive, Hépato-bilio-pancréatique et Transplantation - La Pitié Sâlpêtrière
  • Reims, France, 51100
    • Service de Chirurgie Digestive - CHU Robert Debré
  • Rouen, France, 76000
    • Service de Chirurgie Digestive Hôpital Charles Nicolle - CHU Rouen
  • Strasbourg, France, 67091
    • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
  • Strasbourg, France, 67000
    • Institut de Chirurgie Viscérale - Clinique de l'Orangerie
  • Villejuif, France, 94800
    • Centre Hépato-Biliaire - Hôpital Paul Brousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Investigators: Principal Investigator: Patrick Pessaux, MD, PhD, Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): October 16, 2020
• Study Completion (Actual): October 16, 2020

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: MRI; CT-scan; Surgical planning; 3D model; Hepatocarcinoma eligible for surgical resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: 16-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No