Hepatocarcinoma3D-HAPPINCT03382327
Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas
A study testing Surgical planning in people with Hepatocarcinoma, run by IHU Strasbourg at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocarcinoma
- What is being tested?
- Surgical planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 12 sitesFrance
- Study dates
- 16 Oct 2017to 16 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Service de Chirurgie Digestive - Hôpital Beaujon
Clichy, 92112
Hôpital Henri Mondor - Service de Chirurgie Digestive et Hépatobiliaire -
Créteil, 94010
Service de Chirurgie Digestive et Transplantation - Hôpital Claude Huriez
Lille, 59037
Service de Chirurgie Digestive et Transplantation Hépatique - Hôpital universitaire de la Croix-Rousse
Lyon, 69317
Service de Chirurgie Digestive - CH Emile Muller
Mulhouse, 68100
Chirurgie Viscérale et Digestive - Polyclinique de Gentilly
Nancy, 54100
Chirurgie Digestive, Hépato-bilio-pancréatique et Transplantation - La Pitié Sâlpêtrière
Paris, 75013
Service de Chirurgie Digestive - CHU Robert Debré
Reims, 51100
Service de Chirurgie Digestive Hôpital Charles Nicolle - CHU Rouen
Rouen, 76000
Institut de Chirurgie Viscérale - Clinique de l'Orangerie
Strasbourg, 67000
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Strasbourg, 67091
Centre Hépato-Biliaire - Hôpital Paul Brousse
Villejuif, 94800
About this study
Official title: Multicentric Study Determining the 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.
Read the 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.
- Conditions
- Hepatocarcinoma
- Being tested
- Surgical planning
- Keywords
- Surgical planning, CT-scan, MRI, 3D model, Hepatocarcinoma eligible for surgical resection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical planningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Surgical planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of surgery
Secondary outcomes (10)
Comparison of tumor(s) location
Comparison of tumor(s) location based on 3D model and standard preoperative images analysis.
Measured: At time of surgery
Comparison of vascular network anatomy
Comparison of vascular network anatomy based on 3D model and standard preoperative images analysis.
Measured: 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….)
Measured: At time of surgery
Modification of the initial surgical plan, if applicable
Description of perioperative events having modified the initial surgical plan.
Measured: 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.
Measured: 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.
Measured: At time of surgery
Comparison of surgical merge size
Comparison of surgical merge size (mm) based on 3D model and standard preoperative images analysis.
Measured: At time of surgery
Morbidity
Morbidity specific to the procedure.
Measured: At time of surgery and 3 months after surgery
Mortality
Mortality specific to the procedure.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start16 Oct 2017
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HepatocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Pessaux, MD, PhD, Principal investigator, Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382327
- Sponsor's protocol ID
- 16-003
- Acronym
- 3D-HAPPI
- Status last verified
- Feb 2021
- First submitted
- 14 Nov 2017
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23149461Couinaud 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.
PubMed 12122715Mutter 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.
PubMed 18443871Mutter 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.
PubMed 20932146
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study Determining the Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas
- ClinicalTrials.gov ID
- NCT03382327
- Acronym / sponsor ID
- 3D-HAPPI / 16-003
- Conditions
- Hepatocarcinoma
- Keywords
- Surgical planning, CT-scan, MRI, 3D model, Hepatocarcinoma eligible for surgical resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical planning | Experimental | Procedure: Surgical planningTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical planningTwo 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. | Procedure or surgery | Surgical planning |
Primary outcome
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.
10 secondary outcomes
Comparison of tumor(s) location
Time frame: At time of surgery
Comparison of vascular network anatomy
Time frame: At time of surgery
Choice of surgical plan
Time frame: At time of surgery
Modification of the initial surgical plan, if applicable
Time frame: At time of surgery
Comparison of resection merges
Time frame: At time of surgery
Comparison of resection volumes
Time frame: At time of surgery
Comparison of surgical merge size
Time frame: At time of surgery
Morbidity
Time frame: At time of surgery and 3 months after surgery
Mortality
Time frame: At time of surgery and 3 months after surgery
Preoperative images independent analysis
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 23149461Gauss 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.
- Background: PubMed 12122715Couinaud 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.
- Background: PubMed 18443871Mutter 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.
- Background: PubMed 20932146Mutter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Pessaux, MD, PhD principal investigator
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical planning in people with Hepatocarcinoma, run by IHU Strasbourg at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the intra-operative modifications rates (time frame: At time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03382327, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.