Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Surgery by laparotomy
Trial population
Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Minimal invasive hepatectomy, intraoperative stage
Procedure/SurgeryTrocar 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 stage
Procedure/SurgeryThe 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 collection
Other interventionPatient 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 collection
Other interventionEndoscope calibration. Intraoperative surgical and ultrasound images. Measurements for tumor's size and tumor's distances from liver surface and vascular vascular structures.
Postoperative data collection
Other interventionDefinitive anatomical pathology with the measurement of resection margins.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy5 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
28 monthsSponsors and contacts
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Source ClinicalTrials.gov