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Completed

NCT Number: NCT03382327

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Chirurgie Digestive - Hôpital Beaujon, Clichy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Registry information

Official study title

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

Acronym: 3D-HAPPI

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 22, 2017
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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