AUGUR-AI - Indocyanine Green Fluorescence Angiography Representer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMater Misericordiae University Hospital

About this trial

Surgery can effectively treat colorectal cancer, but it is a complex procedure with risks and complications. Surgeons often rely on cameras to visually guide their instruments during operations, especially in minimally invasive ("keyhole") and endoscopic procedures. The camera is connected to a computer and generates the internal scene onto a display screen, which the surgeon looks at throughout the procedure, helping them make informed decisions throughout the operation. Fluorescence-guided surgery uses a particular type of camera that can detect images in both normal light and in the near-infrared range. To work, it needs the administration of an agent called indocyanine green to a patient and then the camera can see if the agent is in the tissue of interest to the operation at the time of the surgery. In this way, decisions regarding blood supply ("perfusion") can be helped, especially related to safety in joining together portions of tissue after removal of disease. The equipment and agent are approved for use in this way and have very good safety profiles. Many international studies have already demonstrated that the use of fluorescence-guided surgery is associated with lower rates of leaks when disease bowel segments are removed, and the healthy ends are joined back together.

Previous work we have done has shown that sophisticated computing methods can learn to interpret the fluorescence patterns to a similar standard as a surgeon who is very experienced in fluorescence-guided surgery.

In this study, we aim to assess whether the computer system we have developed work in real-time, in theatre to provide a reliable interpretation of the fluorescence pattern, that would match how an expert would interpret the same pattern. The system's analysis will not impact on the operation; instead, video images will be recorded, processed and analysed by our computer system. The results of the interpretation will not be shown to the operating surgeon during the procedure to avoid any impact on decision-making.

Eligibility criteria

Qualifiers

Participant is willing and able to give informed consent for participation in the study.

Aged 18 years or above.

Colorectal disease requiring segmental resection with anastomosis.

Participant has clinically acceptable laboratory results, including liver function tests.

Disqualifiers

Participant who is pregnant, lactating or planning pregnancy during the course of the study.

Significant renal or hepatic impairment.

Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Allergy to intravenous contrast agent or indocyanine green.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

300 Participants
are grouped into 1 trial group

Sponsors and collaborators

Mater Misericordiae University Hospital

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator

Humanitas Research Hospital IRCCS, Rozzano-Milan

Collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborator

University Hospital, Geneva

Collaborator

The Leeds Teaching Hospitals NHS Trust

Collaborator

Oxford University Hospitals NHS Trust

Collaborator

Frimley Park Hospital NHS Trust

Collaborator

IRCCS San Raffaele

Collaborator

UZ Leuven

Collaborator

University College Dublin

Collaborator