Fast Track Pathway to Accelerated Cholecystectomy

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Brief Title

Fast Track Pathway to Accelerated Cholecystectomy

Official Title

Fast Track Pathway to Accelerated Cholecystectomy Versus Standard of Care for Acute cholecysTitis

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.
    


Study Type

Interventional


Primary Outcome

Feasibility (pertaining to patient recruitment)

Secondary Outcome

 Hospital Length of Stay

Condition

Cholecystitis

Intervention

cholecystectomy

Study Arms / Comparison Groups

 Standard of Care
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

60

Start Date

January 22, 2020

Completion Date

February 2021

Primary Completion Date

December 2020

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Flavia Kessler Borges PhD, M.D, 905-527-4322, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04033822

Organization ID

FAST Pilot


Responsible Party

Sponsor-Investigator

Study Sponsor

P.J. Devereaux

Collaborators

 St. Joseph's Health Care London

Study Sponsor

Flavia Kessler Borges PhD, M.D, Principal Investigator, Population Health Research Institute


Verification Date

March 2020