Feasibility and Safety of Augmented Reality (AR) in Liver Tumor Surgery

The purpose of the trial is to evaluate a computer-based Augmented Reality System intended to help surgeons perform keyhole surgery (laparoscopy) for the removal of liver tumors more efficiently and with greater patient safety. In keyhole surgery, the operation is performed using a small camera that is inserted into the abdominal cavity of the patient through surgical trocars placed through small incisions in the skin. The surgeon then performs the operation by guidance from the view from the camera, which shows the surgical area, i.e. the liver and the inside of the abdomen, on a screen in front of them. The clinical trial will evaluate a computer-based system that uses a technology known as augmented reality, or AR. In simple terms, this is a technology that superimposes a computer-generated image on a user's view of the real world, thus providing a composite view. In this case, a computer program will integrate an image showing the tumor's appearance and position inside the liver into the live video feed from the camera, which is then displayed on the existing TV screen, connected to the keyhole camera. Put simply, the AR-projection will appear as an illustrated overlay on the surface of the liver, showing the appearance and position of the tumor throughout the procedure. This may give the surgeon and operating room staff a better understanding of the tumor's location, helping them perform the procedure more safely, accurately and efficiently. To help the computer-based system with positioning of the illustrated overlay correctly on the liver, a small self-adhesive plastic marker, measuring 11x11 mm, will be placed on the surface of the liver while the operation is being carried out. The marker is inserted through the surgical trocars already placed in the abdominal cavity and will be removed from the body before the operation is completed. The purpose of the clinical trial is to assess whether this new technology can help achieve greater accuracy, increased patient safety and a more efficient surgical workflow when tumors in the liver are removed using keyhole surgery. A total of 6 participants will be included in the trial. The clinical trial has been approved by the Swedish Medical Products Agency following an opinion from the Swedish Ethical Review Authority.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Subject scheduled for liver tumor resection of one or more tumors. One tumor per surgery is always chosen as the study tumor and will be removed first.
2. The tumor must be susceptible to uncomplicated wedge resection within one to two segments.
3. The tumor has been diagnosed as malignant or is suspected to be malignant based on imaging or clinical assessment.
4. The tumor's size should not exceed 50 mm in any orientation.
5. Subject 18 years or older.
6. Subject is able to read and understand the Patient information which is written in Swedish.
7. Subject has given consent to study participation.

Exclusion Criteria:

1. Unresectable tumors.
2. Not uncomplicated resection (e.g. central resection, re-resection, or large resection, defined as resection of more than two segments).
3. Subject is not suitable for MIS, as judged by the principal investigator.
4. Subject with reduced kidney function.
5. Subject with known hypersensitivity to contrast agents.
6. Subject considered unable to comply with hospital's instructions, at the discretion of the principal investigator.
7. Subject is not suitable for inclusion in the opinion of the investigator.
8. Pregnant women.