Using AI to improve laparoscopic surgery for gallbladder issues
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
NA · Activ Surgical · NCT05775133
This study is testing whether using artificial intelligence during gallbladder surgery can help surgeons avoid serious injuries and improve patient safety.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Activ Surgical (industry) |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05775133 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an artificial intelligence (AI) model in identifying critical anatomical structures and phases during laparoscopic cholecystectomy compared to traditional methods used by surgeons. Surgeons will perform the procedure as usual while the AI analyzes data from the laparoscopic camera, providing insights without altering the surgeon's view. The goal is to reduce the risk of bile duct injuries, which are serious complications associated with this type of surgery. By documenting the critical view of safety and utilizing intraoperative cholangiography, the study aims to enhance surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old scheduled for elective laparoscopic cholecystectomy due to symptomatic cholelithiasis or cholecystitis.
Not a fit: Patients with contraindications for laparoscopic surgery or those who do not understand the study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of bile duct injuries during laparoscopic cholecystectomy, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using AI for surgical assistance, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- Memorial Hermann Texas Medical Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Peter Kim, MD, PhD — Activ Surgical
- Study coordinator: Christopher McCulloh, MD
- Email: cmcculloh@activsurgical.com
- Phone: 617-333-8162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cholecystitis, Cholelithiasis, Biliary Dyskinesia, artificial intelligence, laparoscopy, laparoscopic surgery