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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Pessaux, MD, PhD | Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Digestive - Hôpital Beaujon | Clichy | 92112 | France | |||
| Hôpital Henri Mondor - Service de Chirurgie Digestive et Hépatobiliaire - |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23149461 | Background | 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. | |
| 12122715 |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| 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 |
| Créteil |
| 94010 |
| France |
| Service de Chirurgie Digestive et Transplantation - Hôpital Claude Huriez | Lille | 59037 | France |
| Service de Chirurgie Digestive et Transplantation Hépatique - Hôpital universitaire de la Croix-Rousse | Lyon | 69317 | France |
| Service de Chirurgie Digestive - CH Emile Muller | Mulhouse | 68100 | France |
| Chirurgie Viscérale et Digestive - Polyclinique de Gentilly | Nancy | 54100 | France |
| Chirurgie Digestive, Hépato-bilio-pancréatique et Transplantation - La Pitié Sâlpêtrière | Paris | 75013 | France |
| Service de Chirurgie Digestive - CHU Robert Debré | Reims | 51100 | France |
| Service de Chirurgie Digestive Hôpital Charles Nicolle - CHU Rouen | Rouen | 76000 | France |
| Institut de Chirurgie Viscérale - Clinique de l'Orangerie | Strasbourg | 67000 | France |
| Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil | Strasbourg | 67091 | France |
| Centre Hépato-Biliaire - Hôpital Paul Brousse | Villejuif | 94800 | France |
| 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. |
| 18443871 | 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. |
| 20932146 | 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. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |