AI Guidance for Gallbladder Surgery

Recruiting at 1 trial location

Overseen By Ariana Walji, BSc, MSc Candidate

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University Health Network, Toronto

Disqualifiers: Non-surgeons, Non-laparoscopic patients, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate (per procedure)

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether artificial intelligence (AI) can make gallbladder removal surgeries safer. The AI, called Artificial Intelligence Guidance Models, guides surgeons by providing a better view and helping them avoid complications. The study compares surgeries using this AI guidance with those that do not, to determine if it improves safety. Individuals over 18, scheduled for gallbladder removal surgery using small incisions, might be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking advancement in surgical safety.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that AI guidance for gallbladder surgery is safe?

Research has shown that using artificial intelligence (AI) in gallbladder surgeries appears promising and safe. Studies have demonstrated that AI tools accurately identify important anatomical features during these surgeries, helping surgeons avoid mistakes. For instance, one study found AI to be 89% accurate with inflammation, 87% accurate with a gallbladder tear, and 77% accurate with a major bile leak.

AI tools have been tested during actual surgeries, providing quick and reliable support to surgeons, even in stressful situations. Previous research indicates that AI enhances surgeons' ability to see and understand critical details, making surgeries safer.

While AI continues to undergo testing in surgeries, these results are encouraging. They suggest the technology is well-received, with no major safety issues reported so far. This could lead to fewer complications for patients, making the surgery process smoother and safer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using artificial intelligence (AI) guidance in gallbladder surgery because it offers a new way to assist surgeons during procedures. Unlike the standard approach, where surgeons rely solely on their expertise and experience, this AI system provides real-time feedback and insights, potentially improving precision and outcomes. The AI models can be toggled on and off, allowing surgeons to customize the level of assistance they receive, which could lead to safer and more efficient surgeries. This innovation could transform how surgeons perform gallbladder surgery, making the process smoother and potentially reducing complications.

What evidence suggests that AI guidance is effective for gallbladder surgery?

Research has shown that AI can greatly improve the accuracy and efficiency of gallbladder surgeries. In this trial, one group of surgeons will perform the standard surgical procedure without AI assistance, while another group will use AI models during their procedures. AI tools have proven to make surgeries safer and more effective, particularly for less experienced surgeons. Specifically, one study found that AI-assisted coaching helped new surgeons perform gallbladder removals more effectively and safely. Additionally, AI can guide surgical decisions, leading to safer outcomes. Overall, these findings suggest that using AI in gallbladder surgeries could help surgeons achieve better results and reduce complications. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients undergoing minimally invasive gallbladder removal surgery (laparoscopic cholecystectomy). Participants should be suitable candidates for this type of surgery. Specific eligibility criteria are not provided, but typically include factors like age, overall health, and the absence of conditions that could complicate surgery.

Inclusion Criteria

I am a surgeon at University Health Network who performs laparoscopic cholecystectomy.

I am an adult scheduled for gallbladder removal surgery.

Exclusion Criteria

Surgeon participants: Anyone who is not a surgeon or fellow at University Health Network or that does not perform laparoscopic cholecystectomies

I am not scheduled for laparoscopic gallbladder removal surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Surgeons perform laparoscopic cholecystectomy procedures with or without AI assistance

Immediate (per procedure)

1 visit (in-person) per procedure

Post-operative Observation

Observations and audio recordings are made during the procedure for analysis

During procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 30-day post-operation chart review

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Artificial Intelligence Guidance Models

Trial Overview The study is testing whether AI guidance models can improve the safety and outcomes of laparoscopic cholecystectomy by assisting surgeons in achieving a critical view of the surgical area. Patients will be randomly assigned to either receive AI assistance during surgery or undergo standard procedures without it.

How Is the Trial Designed?

Group I: Artificial Intelligence Feedback Experimental Treatment 1 Intervention

Surgeons or fellows in the intervention group will have access to two AI models during their procedure. A research coordinator will operate and monitor the AI models, which are displayed on a single monitor in the operating room. Participants may request to toggle between models or turn them off at any point during the procedure, as per their needs.

Group II: Standard Surgical Procedure Active Control 1 Intervention

Surgeons/fellows will perform the procedure, as per standard care measures.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0748798324004372

Artificial intelligence-powered clinical decision making ... This review shows that AI models have the potentiality to select the most optimal treatments for patients undergoing gastrointestinal surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11455722/

Artificial intelligence applied to laparoscopic cholecystectomy Based on the studies reviewed, it emerges that AI could strongly improve surgical efficiency and accuracy during LC.

3. link.springer.com link.springer.com/article/10.1007/s00464-025-12015-6

Using artificial intelligence to model expert panel diagnosis ... A transformer-based AI model can be trained on consensus from an expert panel to predict ratings of cholecystitis severity (Parking Grading ...

4. ijsurgery.com ijsurgery.com/index.php/isj/article/download/10941/6593/52232

Artificial intelligence-based detection of pre-operative ... Background: This study aimed to develop a gradient-based machine learning model to detect and assess potential challenges in laparoscopic ...

5. journals.lww.com journals.lww.com/international-journal-of-surgery/fulltext/2024/12000/impact_of_an_ai_based_laparoscopic_cholecystectomy.39.aspx

Impact of an AI-based laparoscopic cholecystectomy ... The AI-assisted surgical coaching program effectively improved surgical performance and safety for novice surgeons in LC procedures. The model ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666521224000206

Real-time artificial intelligence validation of critical view ... In this study, we sought to investigate the accuracy and performance of a trained Artificial Intelligent (AI) model in validation of the CVS achievement during ...

7. withpower.com withpower.com/trial/phase-3-laparoscopic-cholecystectomy-8-2025-5e7bf

AI Guidance for Gallbladder Surgery Trial Overview The study is testing whether AI guidance models can improve the safety and outcomes of laparoscopic cholecystectomy by assisting surgeons in ...

8. link.springer.com link.springer.com/article/10.1007/s00423-025-03651-6

Systematic review on the use of artificial intelligence to ... This systematic review aims to investigate whether AI can guide surgeons in identifying anatomical structures to facilitate safer dissection during LC.

9. arxiv.org arxiv.org/pdf/2212.06809

Real-Time Artificial Intelligence Assistance for Safe ... This early- stage clinical evaluation shows the feasibility of concurrently attaining real-time, high-quality predictions from several deep neural networks for ...