Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance (IMMORTALLS)

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatectomy; Laparoscopy
• Intervention / Treatment: Procedure: Minimal invasive hepatectomy, intraoperative stage; Procedure: Minimal invasive hepatectomy, postoperative stage; Other: Preoperative data collection; Other: Intraoperative data collection; Other: Postoperative data collection

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Bertrand LE ROY, MD PhD; Phone Number: +33 (0)477120508; Email: bertrand.leroy@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42000
    • Recruiting
    • Chu Saint Etienne
    • Contact: Bertrand LE ROY, MD PhD; Phone Number: +33 (0)477120508; Email: bertrand.leroy@chu-st-etienne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy; Patients undergoing minimally invasive hepatectomy by conventional or robot-assisted laparoscopy will be included.

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.; Procedure: 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.; Other: 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.; Other: Postoperative data collection; Definitive anatomical pathology with the measurement of resection margins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Bertrand LE ROY, MD PhD, Chu Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: augmented reality; laparoscopy; Intraoperative; preoperative; hepatectomy; multimodal data; registration
• Other Study ID Numbers: IRBN952023/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No