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
The goal of this study is to evaluate the utility and efficacy of an artificial intelligence (AI) model at identifying structures and phases of surgery compared to traditional white light assessment by trained surgeons. Surgeons will perform the procedure in their standard practice, while the AI model analyzes data from the laparoscopic camera. Surgeons will be asked to audibly state when they identify structures and enter different phases of the surgical procedure. The AI will not alter the surgeon's view or be visible to the surgeon, and the surgeon will perform the procedure in the exact same fashion as they typically do.
• 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.