IMMORTALLS: Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06044909

Collaborator

(none)

Enrollment

Location

27.6

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatectomy Laparoscopy	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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

Anticipated Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.