Feasibility and Utility of Artificial Intelligence (AI) / Machine Learning (ML) - Driven Advanced Intraoperative Visualization and Identification of Critical Anatomic Structures and Procedural Phases in Laparoscopic Cholecystectomy

Launched by ACTIV SURGICAL · Mar 7, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of artificial intelligence (AI) during laparoscopic cholecystectomy, a type of surgery to remove the gallbladder, which is often needed for conditions like gallstones or inflammation. The main goal is to see how well the AI can help identify important structures and stages of the surgery compared to what experienced surgeons do using standard lighting. During the surgery, the surgeons will continue to work as they normally do, but the AI will be quietly analyzing data from the laparoscopic camera. Surgeons will verbally indicate when they recognize different parts of the surgery, which will help researchers understand how effective the AI is.

To participate in this trial, patients must be at least 18 years old and scheduled for elective laparoscopic cholecystectomy due to gallstones or cholecystitis. They should be able to follow instructions and speak the local language. Eligible patients can come from various backgrounds, including those who have had previous surgeries. Importantly, patients with certain health issues, such as severe kidney problems or pregnancy, cannot participate. If you join this trial, you can expect to receive care from your surgeon as usual, while also contributing to research that could improve surgical techniques in the future.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • All patients age \> 18 years old who are planned for elective laparoscopic cholecystectomy; spoken command and literacy in the native language spoken at each participating center; ability to understand and follow study procedures; and having provided signed consent.
• • Eligible patients will be screened and assigned as per risk calculator for difficulty of LC
• * Diagnosis:
• • All patients with clinical suspicion and diagnosis of symptomatic cholelithiasis or cholecystitis planned for cholecystectomy.
• • Typical imaging as per standard workup findings including US, CT and/or MRI. Plain radiographs and contrast imaging may be obtained by referring physicians and are helpful for confirming the clinical diagnosis.
• * Prior therapy:
• • o Patients with prior surgery are eligible for enrollment.
• * Laboratory:
• • Hemoglobin \> 9 g/dL
• • Platelet count ≥75,000/µL (may receive transfusions)
• • Normal prothrombin time (PT), partial thromboplastin time (PTT) and international normalized ratio (INR) \< 1.5 x upper limit of normal (including patients on prophylactic anticoagulation)
• • Liver Function Test
• • Renal function: Age-adjusted normal serum creatinine
• • Adequate pulmonary function: Defined as no dyspnea at rest, and a pulse oximetry \>94% on room air if there is any clinical indication for determination.
• • Exclusion Criteria
• • Non-elective acute cholecystectomy will be excluded.
• • Patients assigned to FDA cleared ICG-based visualization are contraindicated for any chronic renal dysfunction, potential drug interaction, history of allergy to ICG or anaphylaxis, and pregnancy.
• • Patients eligible for cholecystectomy, exclusion criteria include known allergy to ICG; coagulopathy or known, pre-existing liver disease; pregnancy or breast-feeding; or being of reproductive age with pregnancy possible and not ruled out.
• • Patients currently in any investigational agents.
• • Adults unable to consent
• • Individuals under 18 years of age
• • Pregnant women
• • Prisoners
• • Vulnerable populations