Accelerated Cholecystectomy for Gallbladder Inflammation

(FAST Trial)

Recruiting at 3 trial locations

Overseen By Emily Di Sante, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: P.J. Devereaux

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

More than 10% of Canadians have gallstones, and approximately 10% of these individuals will develop gallbladder inflammation related to gallstones, which is referred to as acute cholecystitis (AC). Patients with AC who do not have their gallbladder surgically removed have a 30% risk of serious complications that can lead to death. Surgery is the only definitive treatment for AC, however, there is controversy regarding the ideal timing of surgery. The two main approaches are early surgery (typically within 7 days of diagnosis) or delayed surgery (7 days to 6 weeks after diagnosis). Although preliminary evidence suggests that early surgery is associated with shorter hospital length of stay, lower risk for complications, and lower costs, practice varies widely regarding the timing of surgery. The limitations of the existing studies include small sample sizes, varied definitions of early versus delayed surgery, and an imbalance of risk between study groups. 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 (i.e., as soon as possible with a goal of surgery within 6 hours of diagnosis) with those who receive standard care.

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.

What data supports the effectiveness of the treatment cholecystectomy for gallbladder inflammation?

Research shows that laparoscopic cholecystectomy, a minimally invasive surgery to remove the gallbladder, is effective for treating acute inflammation of the gallbladder. Studies indicate that the timing of the surgery and the severity of inflammation can influence patient outcomes, with early intervention often leading to better results. ^{1 2 3 4 5}

Is cholecystectomy generally safe for humans?

Cholecystectomy (surgical removal of the gallbladder) is generally considered safe, but like any surgery, it can have risks. Studies show that adverse events (unwanted side effects) can occur, with rates varying depending on factors like bile duct exploration. However, early cholecystectomy for acute conditions appears safe, even in elderly patients and those on antithrombotic drugs. ^{6 7 8 9 10}

How does accelerated cholecystectomy differ from other treatments for gallbladder inflammation?

Accelerated cholecystectomy is unique because it involves performing the surgery to remove the gallbladder within 24 hours of hospital admission, which can reduce post-operative complications and hospital stay compared to delayed surgery. This approach is different from traditional methods that may wait several days before surgery, potentially leading to more severe inflammation and complications. ^{11 12 13 14 15}

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

Eligibility Criteria

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

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

Pregnant patients

My blood thinner medication cannot be stopped.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

The Parkland grading scale for cholecystitis. [2018]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Treatment of acute cholecystitis in patients over 80 years of age]. [2006]

3. Germany pubmed.ncbi.nlm.nih.gov

Laparoscopic cholecystectomy for acute cholecystitis. [2021]

4. Japan pubmed.ncbi.nlm.nih.gov

The Pucker sign: an operative and radiological indicator of impending operative difficulty due to severe chronic contractive inflammation in cholecystectomy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic cholecystectomy for acute inflammation of the gallbladder. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Index versus delayed cholecystectomy in mild gallstone pancreatitis: results of a randomized controlled trial. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Postoperative adverse events of cholecystectomy in the Medicare population. [2019]

8. Pakistan pubmed.ncbi.nlm.nih.gov

Is Surgery Safe in Gallstone-Related Acute Diseases in Elderly Patients? [2017]

9. Pakistan pubmed.ncbi.nlm.nih.gov

Safety of cholecystectomy in patients under antithrombotic Drugs: A systematic review and meta-analysis. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Early cholecystectomy for acute cholecystitis; effect of length of symptoms on morbidity and mortality]. [2006]

11. Germany pubmed.ncbi.nlm.nih.gov

Surgical management of empyematous cholecystitis: a register study of over 12,000 cases from a regional quality control database in Germany. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Timing of early laparoscopic cholecystectomy for acute calculous cholecystitis: a meta-analysis of randomized clinical trials. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

[Topics in the surgical treatment of acute calculous cholecystitis]. [2006]

14. Serbia pubmed.ncbi.nlm.nih.gov

[Acute cholecystitis--early or delayed cholecystectomy]. [2009]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes of early versus delayed cholecystectomy in patients with mild to moderate acute biliary pancreatitis: A randomized prospective study. [2018]