Evaluation of a Protocol for Multidisciplinary Management of Acute Cholecystitis.

Study Overview
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Brief Summary
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Acute cholecystitis is a complex disease and its management is sometimes controversial. Two main factors contribute to its complexity: the patient's surgical risk and the possibility of concomitant choledocholithiasis. The design of a multidisciplinary protocol between the services of Gastroenterology and Surgery aims to harmonize its management and to adapt it to the most recent guidelines. As it concerns more than one department, it is crucial to analyze its compliance and effectiveness.

Detailed Description
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Adult patients attending the emergency department and diagnosed with acute cholecystitis will be asked to participate. Those considered not suitable for surgery will be admitted in a medical department and assigned to conservative treatment or cholecystostomy, according to their acute cholecystitis severity. In patients suitable for surgery, risk of concomitant choledocholithiasis will be assessed and patients will be assigned to low risk or intermediate-high risk. The latter will be admitted in a medical department, and choledocholithiasis will be ruled out and treated if present. The former will be offered cholecystectomy or cholecystostomy according to their surgical risk and acute cholecystitis severity. A flowchart with extended information is attached. PRIMARY OBJECTIVES • To harmonize the management of acute cholecystitis with a multidisciplinary protocol based on the most recent guidelines. SECONDARY OBJECTIVES To analyze the compliance with this protocol. To evaluate the validity of the criteria used in the decision-making process. To assess the morbidity and mortality of different groups of patients according to the selected treatment, severity of cholecystitis and baseline characteristics of the patient. To estimate the resource use in each group of patients. To compare current data with a previous period. To adapt and modify the protocol according the study results. INCLUSION CRITERIA Patients aged 18 or older who agree to participate (an informed consent signature is required) Patients attended in the emergency department of our hospital and diagnosed with acute cholecystitis according to the Tokyo criteria. EXCLUSION CRITERIA Patients under 18 years or patients who refuse to participate in the study Patients diagnosed with acute cholangitis during admission for other causes.

Official Title
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Evaluation of the Applicability and Effectiveness of a Protocol for the Multidisciplinary Management of Acute Cholecystitis

Conditions
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Acute Cholecystitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 or older who agree to participate (an informed consent signature is required) Patients attended in the emergency department of our hospital and diagnosed with acute cholecystitis according to the Tokyo criteria. Exclusion Criteria: Patients under 18 years or patients who refuse to participate in the study Patients diagnosed with acute cholangitis during admission for other causes.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients unfit for Surgery with mild-moderate acute cholecyst<br>Conservative treatment (antibiotics, etc). EUS-guided gallbladder drainage will be considered in recurrent acute cholecystitis and in patients with no improvement in 48-72h after admission. | |
| Patients unfit for Surgery with severe acute cholecystitis<br>Percutaneous cholecystostomy or Endoscopic Ultrasound (EUS)-guided cholecystostomy (the latter is not 24/7 available). Palliative care may also be considered in patients with very serious conditions and low life expectancy. | |
| Patients suitable for Surgery with high and intermediate risk<br>Admission in Gastroenterology Department. antibiotic treatment. Close follow-up of posible AC complications. Once choledocholithiasis is solved or ruled our, the patient will be considered for same-admission cholecystectomy or programmed cholecystectomy. High risk: Endoscopic Retrograde Cholangiopancreatography (ERCP) will be performed. Intermediate risk: EUS or Magnetic Resonance Cholangiopancreatography prior to consider ERCP. | |
| Patients suitable for Surgery with low risk<br>Admission in Surgery Department. According to the AC severity: Mild-moderate AC: check de ASA/Charlson comorbidity index. ASA I-II/Charlson <6: laparoscopic cholecystectomy ASA > =III/Charlson >=6: close follow-up 24-48h. Consider laparoscopic cholecystostomy (if no improvement is achieved) Severe AC: consider Intensive Care Unit admission. Percutaneous cholecystectomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inclusion rate | Rate of patients with AC diagnosis registered in the study | During inclusion period | 
| Protocol compliance | Rate of patients with complete protocol compliance | During inclusion period | 
| Morbidity in the different subtypes of patients | length of hospital stay, need for unplanned readmissions, recurrent cholecystitis | three months after hospital discharge | 
| Mortality in the different subtypes of patients | 90-day disease-specific mortality | three months after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protocol compliance failure | Identify causes of protocol compliance failure | every 3 months throughout study completion (up to 1 year) | 
| Evaluate the technical success | Evaluate clinical success and adverse events of the different treatments. | During inclusion period (up to 1 year) | 
| Evaluate the accuracy in the diagnosis | Evaluate the accuracy of Magnetic Resonance Cholangiopancreatography (MRCP) and EUS in the diagnosis of concomitant choledocholithiasis | three months after hospital discharge or after ERCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute cholecystitis, EUS-guided cholecystostomy, Percutaneous cholecystostomy, Laparoscopic cholecystectomy