Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas
NCT ID: NCT03382327
Last Updated: 2021-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2017-10-16
2020-10-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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IHU Strasbourg
OTHER
Responsible Party
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Principal Investigators
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Patrick Pessaux, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
Locations
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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, , France
Countries
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References
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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.
Other Identifiers
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16-003
Identifier Type: -
Identifier Source: org_study_id
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