Evaluation of a Protocol for Multidisciplinary Management of Acute Cholecystitis.

• Conditions: Acute Cholecystitis

• Registration Number: NCT04543578
• Lead Sponsor: Fundacion Miguel Servet

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-10
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14
• Primary Completion: 2022-07
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain