NCT06044909|Unknown
Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
IMMORTALLS
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IMMORTALLS
Sponsor study identifier
observational
40
1 country
1
Study Start
September 15, 2023
Actual (reported)Primary Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 13, 2023
Actual (reported)September 15, 2023
Actual (reported)September 21, 2023
Actual (reported)January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
28 months
Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy will be included.
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.
Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy
CHU Saint Etienne
Saint-Etienne, 42000, France
Bertrand LE ROY, MD PhD
Centre Hospitalier Universitaire de Saint Etienne
First Submitted
September 13, 2023
First Posted
September 21, 2023
Study Start
September 15, 2023
Actual (reported)Primary Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A Study of Methylprednisolone in People Having Liver 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.
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.
Endoscope calibration. Intraoperative surgical and ultrasound images. Measurements for tumor's size and tumor's distances from liver surface and vascular vascular structures.
Definitive anatomical pathology with the measurement of resection margins.
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Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 20, 2024
Record last verified: 2024-09
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Source: ClinicalTrials.gov.
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