CholecystitisFASTNCT04033822
Fast Track Pathway to Accelerated Cholecystectomy
A study testing cholecystectomy in people with Cholecystitis and Cholecystectomy, run by P.J. Devereaux at 4 sites in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Cholecystectomy
- What is being tested?
- cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesCanada
- Study dates
- 22 Jan 2020to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥45 years; or age ≥18 years and <45 years with at least one of the following co-morbidities: diabetes or chronic respiratory, cardiovascular, or renal disease;
- Diagnosis of acute cholecystitis defined by the presence of at least 2 of the following:
- Abdominal pain in upper right quadrant,
- Murphy's sign,
- Leukocytosis >10 × 103/μl, or
- Oral temperature <36.5°C or >38°C;
Show all 11Show fewer
- Cholelithiasis (stones/sludge);
- Ultrasound signs of cholecystitis;
- Acute cholecystitis that requires surgery and is diagnosed during working hours;
- Expected to require at least an overnight hospital admission after surgery; and
- Provide written informed consent to participate in FAST.
Who cannot join
- Patients requiring emergent surgery or emergent interventions for another reason;
- Patients whose therapeutic anticoagulation is not reversible;
- Patients with a history of heparin-induced thrombocytopenia and current use of warfarin with an INR ≥1.5;
- Pregnant patients;
- Previous participation in the trial.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Hamilton General Hospital
Hamilton, Ontario
Juravinski Hospital
Hamilton, Ontario
St. Joseph's Healthcare
Hamilton, Ontario
Lawson Health Research Institute, London Health Sciences Centre
London, Ontario
About this study
Official title: Fast Track Pathway to Accelerated Cholecystectomy Versus Standard of Care for Acute Cholecystitis
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.
Read the detailed description
The prevalence of gallstones is 10% and approximately 10% of patients develop acute cholecystitis (AC). AC prevalence increases with age and complications are as high as 30% in patients who do not undergo surgery, the only definitive treatment. There is controversy regarding ideal surgical timing. Previously, delayed surgery was thought to decrease bile duct injuries resulting from active inflammation. However, the state of persistent inflammation, hypercoagulability, and stress can cause medical complications such as myocardial injury. Chronic inflammation can lead to fibrosis, adhesions and higher chance of bile duct injuries during delayed surgery. There is also concern for recurrent AC episodes, recurrent pain, biliary pancreatitis, cholangitis or sepsis.
Recent studies suggest that early surgery may be associated with better outcomes, but practice remains variable, ranging anywhere from early surgery (<7 days) to delayed surgery (>7 days). Among >24,000 Ontarians with AC admitted to 106 hospitals, timing of cholecystectomy varied widely across sites. Only 58% of patients underwent surgery within 7 days. High volume hospitals were more likely to perform early surgery.17
Among 14,200 Ontarians with AC, a propensity score analysis demonstrated that early surgery was associated with less bile duct injury (relative risk (RR)=0.53, 95% confidence interval (CI) 0.31-0.90) and shorter length of hospital stay (LOS) (mean 1.9 days, 95% CI 1.7-2.1). Early surgery was less costly and more effective than delayed cholecystectomy.
Trials of surgical timing in patients with AC are limited. The largest randomized controlled trial (RCT) compared early and delayed surgery for AC only included 618 patients.9 Cholecystectomy was performed a median of 1 day after randomization in the early group compared to a median of 25 days in the delayed group. Duration of surgery and conversion rate to open surgery were similar in both groups. Early surgery was associated with less morbidity (11.8% vs. 34.4%, p<0.001), shorter LOS (5.4 vs. 10.0 days, p<0.001), and lower cost (€2919 vs. €4262, p<0.001).
Multiple meta-analyses have suggested that early surgery for AC is associated with fewer wound infections (RR 0.57; 95% CI 0.35-0.93) and have suggested a trend to fewer complications (RR 0.66; 95% CI 0.42-1.03). Limitations of these meta-analyses include studies with small sample sizes, few events, wide confidence intervals, and variation in the definition of early surgery. Finally, there is a lack of strong evidence to make definitive conclusions regarding impact of early surgery in AC, which has led to substantial variation in clinical practice.
AC initiates inflammatory, hypercoagulable, and stress states that can cause medical complications. Early surgical treatment will reduce the time patients are exposed to these harmful states and therefore may reduce the risk of complications. Furthermore, rapid surgery results in a shorter period of AC, which may impact hospital costs. The goal is to undertake a large multicentre RCT of the impact of accelerated surgery (goal within 6 hours of diagnosis) vs. usual timing of surgery in patients with AC on a composite outcome of major clinical and surgical complications at 90 days. "Standard of care", as described, is highly variable and depends on the surgeon and hospital practice patterns.
The main objective of this pilot study is to assess the feasibility of a large trial. The team hypothesizes that accelerated surgery for AC will improve clinical and surgical outcomes. A large RCT on this topic is needed for the following reasons: 1) time to surgery is a modifiable factor; 2) available data are encouraging, but not definitive; 3) there is variation in clinical practice across Ontario and internationally 4) the definition of early surgery has varied substantially across studies; 5) available data may be substantially underestimating the effect of timing of surgery because no trial has evaluated surgery within 6 hours of diagnosis; 6) high-quality evidence will modify clinical practice; and 7) implementation of accelerated surgery could save millions of healthcare dollars annually.
- Conditions
- Cholecystitis, Cholecystectomy
- Being tested
- cholecystectomy
- Keywords
- cholecystitis, cholecystectomy, accelerated surgery, feasibility study
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecystectomyProcedure or surgery
If patients are randomized to the intervention arm of the study; said patient will undergo corrective cholecystectomy surgery to correct cholecystitis as soon as possible with a goal of surgery within 6 hours of diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No 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. |
| FAST Intervention | Experimental | 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. Receives: Procedure: cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (pertaining to patient recruitment)
Proportion of patients who are randomized into the trial.
Measured: 1 year
Feasibility (pertaining to adherence to follow-up assessment)
Proportion of patients with missed assessments and incomplete data variables
Measured: 90 days post-randomization
Feasibility (pertaining to patients who are randomized to Accelerated Care)
Proportion of patients who have surgery initiated within 6 hours of the diagnosis of acute cholecystitis among those randomly assigned to accelerated care.
Measured: Within 6 hours after diagnosis of acute cholecystitis
Secondary outcomes (10)
Hospital Length of Stay
Cumulative length of hospital stay related to acute cholecystitis
Measured: 2 weeks
Proportion of patients who experience e a composite of Clinical Outcomes
Proportion of patients who experience: all-cause mortality, non-fatal sepsis, surgical site infection, pneumonia, Clostridium difficile-associated diarrhea, intra-abdominal abscess, bile duct injury, cystic duct stump leak, conversion to open surgery, intra-abdominal re-operation, intra-abdominal percutaneous or endoscopic re-intervention including placement of drain, embolization or Endoscopic Retrograde Cholangio-Pancreatography (ERCP), cholangitis, pancreatitis, myocardial injury, stroke, venous thromboembolism (VTE), new atrial fibrillation, congestive heart failure, new acute renal injury requiring dialysis and major bleeding.
Measured: 90 days after randomization
Length of surgical procedure
Length of surgical procedure related to acute cholecystitis
Measured: 1 week
Proportion of patients who experience acute kidney injury
Proportion of acute kidney injury events related to acute cholecystitis
Measured: 90 days after randomization
Proportion of patients who are admitted to ICU within 90 days of randomization
Proportion of patients who are admitted to ICU related to acute cholecystitis
Measured: 90 days after randomization
Number of hospital readmissions within 90 days of randomization
Number of hospital readmissions related to acute cholecystitis
Measured: 90 days after randomization
Proportion of patients who experience peripheral arterial thrombosis within 90 days of randomization
Proportion of patients who experience peripheral arterial thrombosis related to acute cholecystitis
Measured: 90 days after randomization
Proportion of patients who experience intra-operative cholangiogram
Rate of Cholangiogram related to acute cholecystitis
Measured: 1 day
Subtotal cholecystectomy rate
Rate of cholecystectomies
Measured: 1 year
Proportion of postoperative ileus
Proportion of postoperative ileus related to acute cholecystitis
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start22 Jan 2020
- Primary completion31 Mar 2022
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Randomized Controlled Trial, efficacy trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- P.J. Devereaux
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Responsible party
- Sponsor-investigator, P.J. Devereaux, Population Health Research Institute
- Investigators
- Flavia Kessler Borges PhD, M.D, Principal investigator, Population Health Research InstituteRahima Nenshi Msc, M.D, Principal investigator, St. Joseph's Health Care LondonPJ Devereaux PhD, M.D, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033822
- Sponsor's protocol ID
- FAST Pilot
- Acronym
- FAST
- Status last verified
- Apr 2025
- First submitted
- 4 Feb 2019
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borges FK, Nenshi R, Serrano PE, Engels P, Vogt K, Park LJ, Di Sante E, Vincent J, Tsiplova K, Devereaux PJ. Fast Track Pathway to Accelerated Cholecystectomy Versus Standard of Care for Acute Cholecystitis (FAST) pilot trial. Can J Surg. 2025 Apr 11;68(2):E122-E131. doi: 10.1503/cjs.016423. Print 2025 Mar-Apr.
PubMed 40216437
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Track Pathway to Accelerated Cholecystectomy Versus Standard of Care for Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT04033822
- Acronym / sponsor ID
- FAST / FAST Pilot
- Conditions
- Cholecystitis, Cholecystectomy
- Keywords
- cholecystitis, cholecystectomy, accelerated surgery, feasibility study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- P.J. DevereauxUniversity, hospital or other
- Collaborators
- St. Joseph's Health Care London
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The prevalence of gallstones is 10% and approximately 10% of patients develop acute cholecystitis (AC). AC prevalence increases with age and complications are as high as 30% in patients who do not undergo surgery, the only definitive treatment. There is controversy regarding ideal surgical timing. Previously, delayed surgery was thought to decrease bile duct injuries resulting from active inflammation. However, the state of persistent inflammation, hypercoagulability, and stress can cause medical complications such as myocardial injury. Chronic inflammation can lead to fibrosis, adhesions and higher chance of bile duct injuries during delayed surgery. There is also concern for recurrent AC episodes, recurrent pain, biliary pancreatitis, cholangitis or sepsis.
Recent studies suggest that early surgery may be associated with better outcomes, but practice remains variable, ranging anywhere from early surgery (<7 days) to delayed surgery (>7 days). Among >24,000 Ontarians with AC admitted to 106 hospitals, timing of cholecystectomy varied widely across sites. Only 58% of patients underwent surgery within 7 days. High volume hospitals were more likely to perform early surgery.17
Among 14,200 Ontarians with AC, a propensity score analysis demonstrated that early surgery was associated with less bile duct injury (relative risk (RR)=0.53, 95% confidence interval (CI) 0.31-0.90) and shorter length of hospital stay (LOS) (mean 1.9 days, 95% CI 1.7-2.1). Early surgery was less costly and more effective than delayed cholecystectomy.
Trials of surgical timing in patients with AC are limited. The largest randomized controlled trial (RCT) compared early and delayed surgery for AC only included 618 patients.9 Cholecystectomy was performed a median of 1 day after randomization in the early group compared to a median of 25 days in the delayed group. Duration of surgery and conversion rate to open surgery were similar in both groups. Early surgery was associated with less morbidity (11.8% vs. 34.4%, p<0.001), shorter LOS (5.4 vs. 10.0 days, p<0.001), and lower cost (€2919 vs. €4262, p<0.001).
Multiple meta-analyses have suggested that early surgery for AC is associated with fewer wound infections (RR 0.57; 95% CI 0.35-0.93) and have suggested a trend to fewer complications (RR 0.66; 95% CI 0.42-1.03). Limitations of these meta-analyses include studies with small sample sizes, few events, wide confidence intervals, and variation in the definition of early surgery. Finally, there is a lack of strong evidence to make definitive conclusions regarding impact of early surgery in AC, which has led to substantial variation in clinical practice.
AC initiates inflammatory, hypercoagulable, and stress states that can cause medical complications. Early surgical treatment will reduce the time patients are exposed to these harmful states and therefore may reduce the risk of complications. Furthermore, rapid surgery results in a shorter period of AC, which may impact hospital costs. The goal is to undertake a large multicentre RCT of the impact of accelerated surgery (goal within 6 hours of diagnosis) vs. usual timing of surgery in patients with AC on a composite outcome of major clinical and surgical complications at 90 days. "Standard of care", as described, is highly variable and depends on the surgeon and hospital practice patterns.
The main objective of this pilot study is to assess the feasibility of a large trial. The team hypothesizes that accelerated surgery for AC will improve clinical and surgical outcomes. A large RCT on this topic is needed for the following reasons: 1) time to surgery is a modifiable factor; 2) available data are encouraging, but not definitive; 3) there is variation in clinical practice across Ontario and internationally 4) the definition of early surgery has varied substantially across studies; 5) available data may be substantially underestimating the effect of timing of surgery because no trial has evaluated surgery within 6 hours of diagnosis; 6) high-quality evidence will modify clinical practice; and 7) implementation of accelerated surgery could save millions of healthcare dollars annually.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Randomized Controlled Trial, efficacy trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No 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. |
| FAST Intervention | Experimental | Procedure: cholecystectomyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥45 years; or age ≥18 years and <45 years with at least one of the following co-morbidities: diabetes or chronic respiratory, cardiovascular, or renal disease;
- Diagnosis of acute cholecystitis defined by the presence of at least 2 of the following:
- Cholelithiasis (stones/sludge);
- Ultrasound signs of cholecystitis;
- Acute cholecystitis that requires surgery and is diagnosed during working hours;
Key exclusion criteria (5 listed)
- Patients requiring emergent surgery or emergent interventions for another reason;
- Patients whose therapeutic anticoagulation is not reversible;
- Patients with a history of heparin-induced thrombocytopenia and current use of warfarin with an INR ≥1.5;
- Pregnant patients;
- Previous participation in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecystectomyIf patients are randomized to the intervention arm of the study; said patient will undergo corrective cholecystectomy surgery to correct cholecystitis as soon as possible with a goal of surgery within 6 hours of diagnosis. | Procedure or surgery | FAST Intervention |
Primary outcome
Feasibility (pertaining to patient recruitment)
Time frame: 1 year
Proportion of patients who are randomized into the trial.
Feasibility (pertaining to adherence to follow-up assessment)
Time frame: 90 days post-randomization
Proportion of patients with missed assessments and incomplete data variables
Feasibility (pertaining to patients who are randomized to Accelerated Care)
Time frame: Within 6 hours after diagnosis of acute cholecystitis
Proportion of patients who have surgery initiated within 6 hours of the diagnosis of acute cholecystitis among those randomly assigned to accelerated care.
10 secondary outcomes
Hospital Length of Stay
Time frame: 2 weeks
Proportion of patients who experience e a composite of Clinical Outcomes
Time frame: 90 days after randomization
Length of surgical procedure
Time frame: 1 week
Proportion of patients who experience acute kidney injury
Time frame: 90 days after randomization
Proportion of patients who are admitted to ICU within 90 days of randomization
Time frame: 90 days after randomization
Number of hospital readmissions within 90 days of randomization
Time frame: 90 days after randomization
Proportion of patients who experience peripheral arterial thrombosis within 90 days of randomization
Time frame: 90 days after randomization
Proportion of patients who experience intra-operative cholangiogram
Time frame: 1 day
Subtotal cholecystectomy rate
Time frame: 1 year
Proportion of postoperative ileus
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 40216437Borges FK, Nenshi R, Serrano PE, Engels P, Vogt K, Park LJ, Di Sante E, Vincent J, Tsiplova K, Devereaux PJ. Fast Track Pathway to Accelerated Cholecystectomy Versus Standard of Care for Acute Cholecystitis (FAST) pilot trial. Can J Surg. 2025 Apr 11;68(2):E122-E131. doi: 10.1503/cjs.016423. Print 2025 Mar-Apr.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecystectomy in people with Cholecystitis and Cholecystectomy, run by P.J. Devereaux at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (pertaining to patient recruitment) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04033822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.