Fast Track Pathway to Accelerated Cholecystectomy

NCT04033822 | Active Not Recruiting

• 1 other identifier: FAST Pilot
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Cholecystitis; Cholecystectomy

Keywords

cholecystitis; cholecystectomy; accelerated surgery; feasibility study

Outcome Measures

Primary Outcomes (3)

• Feasibility (pertaining to patient recruitment)

  Proportion of patients who are randomized into the trial.

  1 year

• Feasibility (pertaining to adherence to follow-up assessment)

  Proportion of patients with missed assessments and incomplete data variables

  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.

  Within 6 hours after diagnosis of acute cholecystitis

Secondary Outcomes (10)

• Hospital Length of Stay

  2 weeks

• Proportion of patients who experience e a composite of Clinical Outcomes

  90 days after randomization

• Length of surgical procedure

  1 week

• Proportion of patients who experience acute kidney injury

  90 days after randomization

• Proportion of patients who are admitted to ICU within 90 days of randomization

  90 days after randomization

Study Arms (2)

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.

Procedure: cholecystectomy

Interventions

cholecystectomy PROCEDURE

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.

FAST Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• P.J. Devereaux: lead
• St. Joseph's Health Care London: collaborator

Study Sites (4)

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Juravinski Hospital

Hamilton, Ontario, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, Canada

Location

Lawson Health Research Institute, London Health Sciences Centre

London, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 40216437 DERIVED

MeSH Terms

Conditions

Cholecystitis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Flavia Kessler Borges PhD, M.D

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Rahima Nenshi Msc, M.D

  St. Joseph's Health Care London

  PRINCIPAL INVESTIGATOR

• PJ Devereaux PhD, M.D

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: allocation group will not be displayed. All personal identifying information will be removed and a computer generated participant ID will be used instead.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PHRI Perioperative and Digital Health Research Director

Model Details: Parallel Randomized Controlled Trial, efficacy trial

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: July 26, 2019
• Study Start: January 22, 2020
• Primary Completion: March 31, 2022
• Study Completion: May 15, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)