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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06044909
Other study ID # IRBN952023/CHUSTE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 15, 2023
Est. completion date January 2026

Study information

Verified date July 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Bertrand LE ROY, MD PhD
Phone (0)477120508
Email bertrand.leroy@chu-st-etienne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
Postoperative data collection
Definitive anatomical pathology with the measurement of resection margins.

Locations

Country Name City State
France CHU Saint Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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