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Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06044909
Acronym
IMMORTALLS
Enrollment
40
Registered
2023-09-21
Start date
2023-09-15
Completion date
2026-01-31
Last updated
2024-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatectomy, Laparoscopy

Keywords

Intraoperative, preoperative, multimodal data, registration, laparoscopy, hepatectomy, augmented reality

Brief 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. 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

PROCEDUREMinimal 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.

PROCEDUREMinimal 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.

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.

OTHERIntraoperative 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.

Definitive anatomical pathology with the measurement of resection margins.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Analysis accuracy of the augmented reality by aligned with the intraoperative measurements28 monthsThe 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.

Countries

France

Contacts

Primary ContactBertrand LE ROY, MD PhD
bertrand.leroy@chu-st-etienne.fr(0)477120508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026