Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

NCT06044909 | Recruiting

• 1 other identifier: IRBN952023/CHUSTE
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Intraoperative; preoperative; multimodal data; registration; laparoscopy; hepatectomy; augmented reality

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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; Procedure: Minimal invasive hepatectomy, postoperative stage; Other: Preoperative data collection; Other: Intraoperative data collection; Other: Postoperative data collection

Interventions

Minimal invasive hepatectomy, intraoperative stage 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.

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

Minimal invasive hepatectomy, postoperative stage 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.

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

Preoperative data collection 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.

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

Intraoperative data collection OTHER

Endoscope calibration. Intraoperative surgical and ultrasound images. Measurements for tumor's size and tumor's distances from liver surface and vascular vascular structures.

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

Postoperative data collection OTHER

Definitive anatomical pathology with the measurement of resection margins.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Surgery by laparotomy

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint Etienne

Saint-Etienne, 42000, France

RECRUITING

Study Officials

• Bertrand LE ROY, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertrand LE ROY, MD PhD

CONTACT

(0)477120508; bertrand.leroy@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: September 15, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)