HepatectomyIMMORTALLSNCT06044909
Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
An observational study of Hepatectomy and Laparoscopy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Multimodal intraoperative minimal-invasive (laparoscopic or robotic) liver surgery images will be registered to each other. Explicitly, these are the ultrasound and laparoscope images. Once they are registered, they will reveal the hidden tumor's location to the surgeon in real time through augmented reality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy, Laparoscopy
- What is being tested?
- Minimal invasive hepatectomy, intraoperative stage, Minimal invasive hepatectomy, postoperative stage and Preoperative data collection
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2023to Jan 2026
- Phase
- Observational
- 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
Study population: Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy
Who may be able to join
- Patients undergoing hepatectomy;
- Patients for whom good-quality imaging is available (CT scan and/or MRI and/or ultrasound);
- Patients over 18 years of age;
- Minimally invasive surgery by conventional or robot-assisted laparoscopy.
Who cannot join
- Surgery by laparotomy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Saint Etienne
Saint-Etienne, 42000
Bertrand LE ROY, MD PhD, (0)477120508 ext. +33, bertrand.leroy@chu-st-etienne.fr
About this study
Multimodal intraoperative minimal-invasive (laparoscopic or robotic) liver surgery images will be registered to each other. Explicitly, these are the ultrasound and laparoscope images. Once they are registered, they will reveal the hidden tumor's location to the surgeon in real time through augmented reality. The intraoperative augmentation will also be enriched with the preoperative data (e.g., CT or MRI). This will simplify minimal invasive liver surgery, improve surgical safety and accuracy. It will also shorten hospital stays and contribute to an overall better quality of life for the patient, which in return will reduce the health-care costs.
- Conditions
- Hepatectomy, Laparoscopy
- Being tested
- Minimal invasive hepatectomy, intraoperative stage, Minimal invasive hepatectomy, postoperative stage, Preoperative data collection, Intraoperative data collection, Postoperative data collection
- Keywords
- Intraoperative, preoperative, multimodal data, registration, laparoscopy, hepatectomy, augmented reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal invasive hepatectomy, intraoperative stageProcedure or surgery
Trocar layout is recorded by photo or diagram. The video of conventional or robot-assisted laparoscopy and intraoperative laparoscopic ultrasound images (where applicable) are recorded by the surgeon and anonymized. Depth measurements of internal structures (tumors, cysts, vascular network, anatomical landmarks) are taken using identifiable points on the surface of the liver for tumour resection.
Minimal invasive hepatectomy, postoperative stageProcedure or surgery
The registration of imaging data in conventional or robot-assisted laparoscopy is performed by the scientific team using the developed registration algorithm. The data obtained from the clinical intervention will help improve the registration algorithm.
Preoperative data collectionOther
Patient code (anonymised) + inclusion number, repeated on each page. Anonymised CT or MRI scan and date of scan. Type of cancer, planned surgery and approach (robotic or laparoscopic). Patient's age. Patient's surgical history. Toxic habits: tobacco, alcohol. Healthy liver, liver disease, cirrhosis. Anticoagulant and antiaggregant treatment.
Intraoperative data collectionOther
Endoscope calibration. Intraoperative surgical and ultrasound images. Measurements for tumor's size and tumor's distances from liver surface and vascular vascular structures.
Postoperative data collectionOther
Definitive anatomical pathology with the measurement of resection margins.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy | Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy will be included. Receives: Procedure: Minimal invasive hepatectomy, intraoperative stage; Procedure: Minimal invasive hepatectomy, postoperative stage; Other: Preoperative data collection; Other: Intraoperative data collection; Other: Postoperative data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis accuracy of the augmented reality by aligned with the intraoperative measurements
The accuracy of the augmented reality will be assessed based on how well the preoperative data will be aligned with the intraoperative measurements. In order to assess the accuracy, measurements of multiple distances between the center of mass (mean position) of different internal structures (tumors, anatomical vascular networks, anatomical landmarks) visible both in the preoperative imaging and in the intraoperative imaging will be used.
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Sep 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand LE ROY, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044909
- Sponsor's protocol ID
- IRBN952023/CHUSTE
- Acronym
- IMMORTALLS
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
- ClinicalTrials.gov ID
- NCT06044909
- Acronym / sponsor ID
- IMMORTALLS / IRBN952023/CHUSTE
- Conditions
- Hepatectomy, Laparoscopy
- Keywords
- Intraoperative, preoperative, multimodal data, registration, laparoscopy, hepatectomy, augmented reality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
Multimodal intraoperative minimal-invasive (laparoscopic or robotic) liver surgery images will be registered to each other. Explicitly, these are the ultrasound and laparoscope images. Once they are registered, they will reveal the hidden tumor's location to the surgeon in real time through augmented reality. The intraoperative augmentation will also be enriched with the preoperative data (e.g., CT or MRI). This will simplify minimal invasive liver surgery, improve surgical safety and accuracy. It will also shorten hospital stays and contribute to an overall better quality of life for the patient, which in return will reduce the health-care costs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy | – | Procedure: Minimal invasive hepatectomy, intraoperative stage, Procedure: Minimal invasive hepatectomy, postoperative stage, Other: Preoperative data collection, Other: Intraoperative data collection, Other: Postoperative data collectionPatients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy
Key inclusion criteria (4 listed)
- Patients undergoing hepatectomy;
- Patients for whom good-quality imaging is available (CT scan and/or MRI and/or ultrasound);
- Patients over 18 years of age;
- Minimally invasive surgery by conventional or robot-assisted laparoscopy.
Key exclusion criteria (1 listed)
- Surgery by laparotomy
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 |
|---|---|---|
| Minimal invasive hepatectomy, intraoperative stageTrocar layout is recorded by photo or diagram. The video of conventional or robot-assisted laparoscopy and intraoperative laparoscopic ultrasound images (where applicable) are recorded by the surgeon and anonymized. Depth measurements of internal structures (tumors, cysts, vascular network, anatomical landmarks) are taken using identifiable points on the surface of the liver for tumour resection. | Procedure or surgery | Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy |
| Minimal invasive hepatectomy, postoperative stageThe registration of imaging data in conventional or robot-assisted laparoscopy is performed by the scientific team using the developed registration algorithm. The data obtained from the clinical intervention will help improve the registration algorithm. | Procedure or surgery | Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy |
| Preoperative data collectionPatient code (anonymised) + inclusion number, repeated on each page. Anonymised CT or MRI scan and date of scan. Type of cancer, planned surgery and approach (robotic or laparoscopic). Patient's age. Patient's surgical history. Toxic habits: tobacco, alcohol. Healthy liver, liver disease, cirrhosis. Anticoagulant and antiaggregant treatment. | Other | Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy |
| Intraoperative data collectionEndoscope calibration. Intraoperative surgical and ultrasound images. Measurements for tumor's size and tumor's distances from liver surface and vascular vascular structures. | Other | Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy |
| Postoperative data collectionDefinitive anatomical pathology with the measurement of resection margins. | Other | Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy |
Primary outcome
Analysis accuracy of the augmented reality by aligned with the intraoperative measurements
Time frame: 28 months
The accuracy of the augmented reality will be assessed based on how well the preoperative data will be aligned with the intraoperative measurements. In order to assess the accuracy, measurements of multiple distances between the center of mass (mean position) of different internal structures (tumors, anatomical vascular networks, anatomical landmarks) visible both in the preoperative imaging and in the intraoperative imaging will be used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Bertrand LE ROY, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatectomy and Laparoscopy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertrand LE ROY, MD PhD ((0)477120508 ext. +33, bertrand.leroy@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis accuracy of the augmented reality by aligned with the intraoperative measurements (time frame: 28 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2024.