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

NCT03382327 | Completed

• 1 other identifier: 16-003
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 12

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.

Conditions

Hepatocarcinoma

Keywords

Surgical planning; CT-scan; MRI; 3D model; Hepatocarcinoma eligible for surgical resection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Comparison of tumor(s) location

  At time of surgery

• Comparison of vascular network anatomy

  At time of surgery

• Choice of surgical plan

  At time of surgery

• Modification of the initial surgical plan, if applicable

  At time of surgery

• Comparison of resection merges

  At time of surgery

Study Arms (1)

Surgical planning

EXPERIMENTAL

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

Interventions

Surgical planning PROCEDURE

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.

Surgical planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 custody
• Patient under guardianship.

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (12)

Service de Chirurgie Digestive - Hôpital Beaujon

Clichy, 92112, France

Location

Hôpital Henri Mondor - Service de Chirurgie Digestive et Hépatobiliaire -

Créteil, 94010, France

Location

Service de Chirurgie Digestive et Transplantation - Hôpital Claude Huriez

Lille, 59037, France

Location

Service de Chirurgie Digestive et Transplantation Hépatique - Hôpital universitaire de la Croix-Rousse

Lyon, 69317, France

Location

Service de Chirurgie Digestive - CH Emile Muller

Mulhouse, 68100, France

Location

Chirurgie Viscérale et Digestive - Polyclinique de Gentilly

Nancy, 54100, France

Location

Chirurgie Digestive, Hépato-bilio-pancréatique et Transplantation - La Pitié Sâlpêtrière

Paris, 75013, France

Location

Service de Chirurgie Digestive - CHU Robert Debré

Reims, 51100, France

Location

Service de Chirurgie Digestive Hôpital Charles Nicolle - CHU Rouen

Rouen, 76000, France

Location

Institut de Chirurgie Viscérale - Clinique de l'Orangerie

Strasbourg, 67000, France

Location

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Centre Hépato-Biliaire - Hôpital Paul Brousse

Villejuif, 94800, France

Location

Related Publications (4)

• 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.

  PMID: 23149461 BACKGROUND

• 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.

  PMID: 12122715 BACKGROUND

• 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.

  PMID: 18443871 BACKGROUND

• 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.

  PMID: 20932146 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Patrick Pessaux, MD, PhD

  Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 22, 2017
• Study Start: October 16, 2017
• Primary Completion: October 16, 2020
• Study Completion: October 16, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

FR (12)