Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06044909

Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hepatectomy Laparoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint Etienne

Saint-Etienne, 42000, France

Location status: Recruiting

Location contact

Bertrand LE ROY, MD PhD

CONTACT

[email protected]

(0)477120508 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Postoperative data collection

Other

Definitive anatomical pathology with the measurement of resection margins.

Primary outcomes

  1. Analysis accuracy of the augmented reality by aligned with the intraoperative measurements

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bertrand LE ROY, MD PhD

CONTACT

[email protected]

(0)477120508 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: IMMORTALLS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.