Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Minimal invasive hepatectomy, intraoperative stage, Minimal invasive hepatectomy, postoperative stage, Preoperative data collection, Intraoperative data collection.
- Who it may be relevant to
- Registry conditions: Hepatectomy, Laparoscopy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Minimal invasive hepatectomy, intraoperative stage
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. - Procedure Minimal invasive hepatectomy, postoperative stage
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. - Other Preoperative data collection
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. - Other Intraoperative data collection
Endoscope calibration. Intraoperative surgical and ultrasound images. Measurements for tumor's size and tumor's distances from liver surface and vascular vascular structures. - Other Postoperative data collection
Definitive anatomical pathology with the measurement of resection margins.
Primary outcome measures
- Analysis accuracy of the augmented reality by aligned with the intraoperative measurements [Time frame: 28 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Surgery by laparotomy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU Saint Etienne — Saint-Etienne
Identifiers
NCT: NCT06044909 · IRBN952023/CHUSTE