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Fast Track Pathway to Accelerated Cholecystectomy (FAST)

Primary Purpose

Cholecystitis, Cholecystectomy

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
cholecystectomy
Sponsored by
P.J. Devereaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis focused on measuring cholecystitis, cholecystectomy, accelerated surgery, feasibility study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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;
  2. Diagnosis of acute cholecystitis defined by the presence of at least 2 of the following:

    1. Abdominal pain in upper right quadrant,
    2. Murphy's sign,
    3. Leukocytosis >10 × 103/μl, or
    4. Oral temperature <36.5°C or >38°C;
  3. Cholelithiasis (stones/sludge);
  4. Ultrasound signs of cholecystitis;
  5. Acute cholecystitis that requires surgery and is diagnosed during working hours;
  6. Expected to require at least an overnight hospital admission after surgery; and
  7. Provide written informed consent to participate in FAST.

Exclusion Criteria

  1. Patients requiring emergent surgery or emergent interventions for another reason;
  2. Patients whose therapeutic anticoagulation is not reversible;
  3. Patients with a history of heparin-induced thrombocytopenia and current use of warfarin with an INR ≥1.5;
  4. Pregnant patients;
  5. Previous participation in the trial.

Sites / Locations

  • Hamilton General Hospital
  • Juravinski Hospital
  • St. Joseph's Healthcare
  • Lawson Health Research Institute, London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

FAST Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility (pertaining to patient recruitment)
Proportion of patients who are randomized into the trial.
Feasibility (pertaining to adherence to follow-up assessment)
Proportion of patients with missed assessments and incomplete data variables
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.

Secondary Outcome Measures

Hospital Length of Stay
Cumulative length of hospital stay related to acute cholecystitis
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.
Length of surgical procedure
Length of surgical procedure related to acute cholecystitis
Proportion of patients who experience acute kidney injury
Proportion of acute kidney injury events related to acute cholecystitis
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
Number of hospital readmissions within 90 days of randomization
Number of hospital readmissions related to acute cholecystitis
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
Proportion of patients who experience intra-operative cholangiogram
Rate of Cholangiogram related to acute cholecystitis
Subtotal cholecystectomy rate
Rate of cholecystectomies
Proportion of postoperative ileus
Proportion of postoperative ileus related to acute cholecystitis

Full Information

First Posted
February 4, 2019
Last Updated
February 8, 2023
Sponsor
P.J. Devereaux
Collaborators
St. Joseph's Health Care London
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1. Study Identification

Unique Protocol Identification Number
NCT04033822
Brief Title
Fast Track Pathway to Accelerated Cholecystectomy
Acronym
FAST
Official Title
Fast Track Pathway to Accelerated Cholecystectomy Versus Standard of Care for Acute Cholecystitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
P.J. Devereaux
Collaborators
St. Joseph's Health Care London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Cholecystectomy
Keywords
cholecystitis, cholecystectomy, accelerated surgery, feasibility study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Randomized Controlled Trial, efficacy trial
Masking
Outcomes Assessor
Masking Description
allocation group will not be displayed. All personal identifying information will be removed and a computer generated participant ID will be used instead.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
FAST Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
cholecystectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility (pertaining to patient recruitment)
Description
Proportion of patients who are randomized into the trial.
Time Frame
1 year
Title
Feasibility (pertaining to adherence to follow-up assessment)
Description
Proportion of patients with missed assessments and incomplete data variables
Time Frame
90 days post-randomization
Title
Feasibility (pertaining to patients who are randomized to Accelerated Care)
Description
Proportion of patients who have surgery initiated within 6 hours of the diagnosis of acute cholecystitis among those randomly assigned to accelerated care.
Time Frame
Within 6 hours after diagnosis of acute cholecystitis
Secondary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Cumulative length of hospital stay related to acute cholecystitis
Time Frame
2 weeks
Title
Proportion of patients who experience e a composite of Clinical Outcomes
Description
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.
Time Frame
90 days after randomization
Title
Length of surgical procedure
Description
Length of surgical procedure related to acute cholecystitis
Time Frame
1 week
Title
Proportion of patients who experience acute kidney injury
Description
Proportion of acute kidney injury events related to acute cholecystitis
Time Frame
90 days after randomization
Title
Proportion of patients who are admitted to ICU within 90 days of randomization
Description
Proportion of patients who are admitted to ICU related to acute cholecystitis
Time Frame
90 days after randomization
Title
Number of hospital readmissions within 90 days of randomization
Description
Number of hospital readmissions related to acute cholecystitis
Time Frame
90 days after randomization
Title
Proportion of patients who experience peripheral arterial thrombosis within 90 days of randomization
Description
Proportion of patients who experience peripheral arterial thrombosis related to acute cholecystitis
Time Frame
90 days after randomization
Title
Proportion of patients who experience intra-operative cholangiogram
Description
Rate of Cholangiogram related to acute cholecystitis
Time Frame
1 day
Title
Subtotal cholecystectomy rate
Description
Rate of cholecystectomies
Time Frame
1 year
Title
Proportion of postoperative ileus
Description
Proportion of postoperative ileus related to acute cholecystitis
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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. Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavia Kessler Borges PhD, M.D
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rahima Nenshi Msc, M.D
Organizational Affiliation
St. Joseph's Health Care London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PJ Devereaux PhD, M.D
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Juravinski Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Lawson Health Research Institute, London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Fast Track Pathway to Accelerated Cholecystectomy

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