Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

Recruiting

• Conditions: Hepatectomy; Laparoscopy
• Interventions: Procedure: Minimal invasive hepatectomy, intraoperative stage; Procedure: Minimal invasive hepatectomy, postoperative stage; Other: Preoperative data collection; Other: Intraoperative data collection; Other: Postoperative data collection

• Registration Number: NCT06044909
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-13
• Study Start: 2023-09-15
• Study First Posted: 2023-09-21
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy	Minimal invasive hepatectomy, intraoperative stage	Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy will be included.
Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy	Intraoperative data collection	Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy will be included.
Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy	Minimal invasive hepatectomy, postoperative stage	Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy will be included.
Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy	Preoperative data collection	Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy will be included.
Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy	Postoperative data collection	Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy will be included.

Primary Outcome Measures

Name	Time	Method
Analysis accuracy of the augmented reality by aligned with the intraoperative measurements	28 months	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.

Trial Locations

Locations (1)

CHU Saint Etienne; 🇫🇷 Saint-Étienne, France