Accelerated Cholecystectomy for Gallbladder Inflammation

(FAST Trial)

Not currently recruiting at 3 trial locations

Overseen By Emily Di Sante, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: P.J. Devereaux

Must not be taking: Warfarin

Disqualifiers: Emergent surgery, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the timing of gallbladder removal surgery (cholecystectomy) for individuals with gallbladder inflammation caused by gallstones. It compares immediate surgery after diagnosis with the usual timing, which can be up to six weeks later. The trial aims to determine if faster surgery results in better outcomes, such as fewer complications and shorter hospital stays. Suitable candidates for this trial have been diagnosed with gallbladder inflammation, require surgery, and experience symptoms like upper right belly pain or fever. As an unphased trial, it provides patients the opportunity to contribute to understanding the optimal timing for surgery to improve health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on therapeutic anticoagulation that cannot be reversed, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that having gallbladder removal surgery sooner can lead to better outcomes by reducing the time patients spend in harmful conditions, such as inflammation. Patients who undergo the surgery earlier often experience fewer complications and shorter hospital stays.

For safety, earlier surgery is generally well-tolerated. It is a common procedure and has been performed safely for many years. While all surgeries carry risks, evidence suggests that earlier surgery might lower overall risks.

Overall, the safety of earlier surgery is comparable to waiting, but it may result in a quicker recovery and fewer complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the accelerated cholecystectomy approach because it aims to perform gallbladder removal surgery within just 6 hours of diagnosing cholecystitis, which is an inflammation of the gallbladder. Traditionally, patients might experience delays in surgery due to scheduling and preparation, which can prolong discomfort and the risk of complications. By speeding up the timeline, the accelerated method could potentially reduce hospital stays, lower the chance of complications, and improve recovery times for patients. This swift intervention is what sets it apart from the standard of care, offering a quicker path to relief and recovery.

What evidence suggests that accelerated cholecystectomy might be an effective treatment for gallbladder inflammation?

Research has shown that prompt gallbladder removal surgery may lead to better outcomes for people with acute cholecystitis, an inflammation of the gallbladder. In this trial, participants in the FAST intervention arm will undergo surgery as soon as possible, aiming for surgery within 6 hours of diagnosis. Studies have found that immediate surgery reduces harmful bodily responses, such as inflammation, and helps prevent complications. Early surgery also appears to lower the risk of bile duct injuries and other issues that can arise from delayed treatment. Although current evidence comes from smaller studies, early findings suggest that faster surgery could result in shorter hospital stays and lower overall costs. This trial further investigates whether this approach consistently provides these benefits. ^{1 2 3 5 6}

Who Is on the Research Team?

Flavia Kessler Borges PhD, M.D

Principal Investigator

Population Health Research Institute

Rahima Nenshi Msc, M.D

Principal Investigator

St. Joseph's Health Care London

PJ Devereaux PhD, M.D

Principal Investigator

Hamilton Health Sciences Corporation

Are You a Good Fit for This Trial?

This trial is for adults over 45, or those 18-44 with diabetes or chronic heart, lung, or kidney disease. They must have gallbladder inflammation diagnosed by specific symptoms and tests, need surgery during working hours, and stay in the hospital overnight post-surgery. Excluded are those previously in this trial, needing urgent surgery for other reasons, on certain blood thinners, with a history of specific clotting disorders or pregnant.

Inclusion Criteria

I am 45 years old or older.

I have been diagnosed with acute cholecystitis and need surgery.

Exclusion Criteria

Pregnant patients

Previous participation in the trial

I need emergency surgery or intervention for a different health issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo accelerated cholecystectomy surgery as soon as possible with a goal of surgery within 6 hours of diagnosis

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical outcomes and complications

90 days

Standard of Care

Participants receive standard care without accelerated surgery, continuing with care as originally provided by the healthcare system

Varies

What Are the Treatments Tested in This Trial?

Interventions

• cholecystectomy

Trial Overview The study is testing if removing the gallbladder within 6 hours of diagnosing acute cholecystitis (inflammation due to gallstones) leads to better outcomes compared to standard timing. It aims to set up a larger trial based on these results.

How Is the Trial Designed?

Group I: FAST Intervention Experimental Treatment 1 Intervention

Patients diagnosed with cholecystitis and randomized to the FAST intervention arm of the study will undergo surgery as soon as possible with a goal of surgery within 6 hours of diagnosis.

Group II: Standard of Care Active Control 1 Intervention

Patients randomized to the standard of care arm of the trial will not receive accelerated cholecystectomy surgery to correct cholecystitis. No services will be taken away but patients will continue with care as originally provided by the healthcare system.

Who Is Running the Clinical Trial?

P.J. Devereaux

Lead Sponsor

Trials

1

Recruited

60+

St. Joseph's Health Care London

Collaborator

Trials

28

Recruited

2,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11999720/

Fast Track Pathway to Accelerated Cholecystectomy ... Accelerated surgery may result in better outcomes owing to reduced exposure to hypercoagulable and inflammatory states. We sought to determine ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04033822

Fast Track Pathway to Accelerated Cholecystectomy ... The proposed pilot study aims to inform the design of a large clinical trial that will compare the outcomes of patients with AC who receive accelerated surgery ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40216437/

Fast Track Pathway to Accelerated Cholecystectomy ... Accelerated surgery may result in better outcomes owing to reduced exposure to hypercoagulable and inflammatory states. We sought to determine ...

4. clinicaltrial.be clinicaltrial.be/en/details/4984?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Fast Track Pathway to Accelerated Cholecystectomy - Clini... Chronic inflammation can lead to fibrosis, adhesions and higher chance of bile duct injuries during delayed surgery. There is also concern for ...

5. researchgate.net researchgate.net/publication/390717039_Fast_Track_Pathway_to_Accelerated_Cholecystectomy_Versus_Standard_of_Care_for_Acute_Cholecystitis_FAST_pilot_trial

(PDF) Fast Track Pathway to Accelerated Cholecystectomy ... Accelerated surgery may result in better outcomes owing to reduced exposure to hypercoagulable and inflammatory states. We sought to determine ...

6. canjsurg.ca canjsurg.ca/content/68/2/E122

Fast Track Pathway to Accelerated Cholecystectomy ... Accelerated surgery may result in better outcomes owing to reduced exposure to hypercoagulable and inflammatory states. We sought to determine ...