Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

NCT ID: NCT06044909

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2026-01-31

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.

Conditions

Hepatectomy; Laparoscopy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Minimal invasive hepatectomy, intraoperative stage

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Preoperative data collection

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Definitive anatomical pathology with the measurement of resection margins.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

Intervention Type: 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.

Intervention Type: OTHER

Postoperative data collection

Definitive anatomical pathology with the measurement of resection margins.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertrand LE ROY, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU Saint Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Bertrand LE ROY, MD PhD

Role: CONTACT

bertrand.leroy@chu-st-etienne.fr

(0)477120508 ext. +33

Facility Contacts

Bertrand LE ROY, MD PhD

Role: primary

bertrand.leroy@chu-st-etienne.fr

(0)477120508 ext. +33

Other Identifiers

IRBN952023/CHUSTE

Identifier Type: -

Identifier Source: org_study_id