Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

Laparoscopy Clinical Trial

— IMMORTALLS  

Official title:

Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044909
• Other study ID #: IRBN952023/CHUSTE
• Status: Recruiting
• Start date: September 15, 2023
• Est. completion date: January 2026

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Bertrand LE ROY, MD PhD
• Phone: (0)477120508
• Email: bertrand.leroy[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatectomy
• Laparoscopy

Intervention

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.
• 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.
• 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.
• Postoperative data collection
Definitive anatomical pathology with the measurement of resection margins.

Locations

Country	Name	City	State
France	CHU Saint Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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