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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03382327
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : December 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatocarcinoma Procedure: Surgical planning Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Multicentric Study Determining the Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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.




Primary Outcome Measures :
  1. Comparison of the intra-operative modifications rates [ Time Frame: 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 :
  1. Comparison of tumor(s) location [ Time Frame: At time of surgery ]
    Comparison of tumor(s) location based on 3D model and standard preoperative images analysis.

  2. Comparison of vascular network anatomy [ Time Frame: At time of surgery ]
    Comparison of vascular network anatomy based on 3D model and standard preoperative images analysis.

  3. Choice of surgical plan [ Time Frame: 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….)

  4. Modification of the initial surgical plan, if applicable [ Time Frame: At time of surgery ]
    Description of perioperative events having modified the initial surgical plan.

  5. Comparison of resection merges [ Time Frame: 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.

  6. Comparison of resection volumes [ Time Frame: 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.

  7. Comparison of surgical merge size [ Time Frame: At time of surgery ]
    Comparison of surgical merge size (mm) based on 3D model and standard preoperative images analysis.

  8. Morbidity [ Time Frame: At time of surgery and 3 months after surgery ]
    Morbidity specific to the procedure.

  9. Mortality [ Time Frame: At time of surgery and 3 months after surgery ]
    Mortality specific to the procedure.

  10. Preoperative images independent analysis [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382327


Contacts
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Contact: Patrick Pessaux, MD, PhD +33 3 69 55 05 52 patrick.pessaux@chru-strasbourg.fr

Locations
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France
Service de Chirurgie Digestive - Hôpital Beaujon Not yet recruiting
Clichy, France, 92112
Contact: Olivier Soubrane, MD, PhD    +33 1 40 87 58 95    olivier.soubrane@aphp.fr   
Hôpital Henri Mondor - Service de Chirurgie Digestive et Hépatobiliaire - Active, not recruiting
Créteil, France, 94010
Service de Chirurgie Digestive et Transplantation - Hôpital Claude Huriez Recruiting
Lille, France, 59037
Contact: Emmanuel BOLESLAWSKI, Pr    + 33 (0)6 19 84 01 41    Emmanuel.BOLESLAWSKI@chru-lille.fr   
Service de Chirurgie Digestive et Transplantation Hépatique - Hôpital universitaire de la Croix-Rousse Active, not recruiting
Lyon, France, 69317
Service de Chirurgie Digestive - CH Emile Muller Recruiting
Mulhouse, France, 68100
Contact: Thomas Zacharias, MD    +33 3 89 64 73 55    zachariast@ch-mulhouse.fr   
Chirurgie Viscérale et Digestive - Polyclinique de Gentilly Active, not recruiting
Nancy, France, 54100
Chirurgie Digestive, Hépato-bilio-pancréatique et Transplantation - La Pitié Sâlpêtrière Recruiting
Paris, France, 75013
Contact: Olivier Scatton, MD, PhD    + 33 1 84 82 74 27    olivier.scatton@psl.aphp.fr   
Service de Chirurgie Digestive - CHU Robert Debré Recruiting
Reims, France, 51100
Contact: Daniele Sommacale, MD, PhD    +33 3 26 78 70 95    dsommacale@chu-reims.fr   
Service de Chirurgie Digestive Hôpital Charles Nicolle - CHU Rouen Recruiting
Rouen, France, 76000
Contact: Jean-Jacques Tuech, Pr    +33 (0)2 32 88 89 90    jean-jacques.tuech@chu-rouen.fr   
Contact: Lilian Schwarz, Dr       lilian.schwarz@chu-rouen.fr   
Institut de Chirurgie Viscérale - Clinique de l'Orangerie Not yet recruiting
Strasbourg, France, 67000
Contact: Jean-Christophe WEBER, Dr    +33 (0)6 74 90 01 20    jcweber3@mac.com   
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Patrick Pessaux, MD, PhD    +33 3 69 55 05 52    patrick.pessaux@chru-strasbourg.fr   
Centre Hépato-Biliaire - Hôpital Paul Brousse Active, not recruiting
Villejuif, France, 94800
Sponsors and Collaborators
IHU Strasbourg
Investigators
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Principal Investigator: Patrick Pessaux, MD, PhD Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Publications:
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Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT03382327    
Other Study ID Numbers: 16-003
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: December 26, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IHU Strasbourg:
Surgical planning
CT-scan
MRI
3D model
Hepatocarcinoma eligible for surgical resection
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases