Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors

• Conditions: Acute Cholecystitis; Choledocholithiasis

• Registration Number: NCT04739891
• Lead Sponsor: Hospital de Mataró

Brief Summary

The management of cholelithiasis with choledocolithiasis is extensively known, whereas for Acute Calculous Cholecystitis (ACC) with choledocolithiasis or common bile duct stones (CBDS), a common entity, there is a lack of protocols for optimising treatment. The main hypothesis of our study is: a correct stratification of the concomitant CBDS probability at ACC diagnosis would optimize its treatment as early targeted treatment could be performed. One-step management of ACC with CBDS by a specialised hepatobiliary team would represent a benefit to the patient in terms of morbi-mortality, admission time and number of admissions. The aim of our study is to identify high / intermediate probability criteria for CBDS associated when diagnosing CA. This is a retrospective study of patients who were operated on with an emergent cholecystectomy in our center from 01/2012 to 12/2019.

Detailed Description

Data will be obtained from the hospital (Consorci Sanitari del Maresme) clinical database.

The Ethics Committee approval has been obtained.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Last Update Submitted: 2021-02-01
• Study First Posted: 2021-02-05
• Last Update Posted: 2021-02-05
• Study Start: 2021-02-15
• Primary Completion: 2021-04-15
• Study Completion: 2021-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age ≥18 years

Exclusion Criteria

• Non urgent cholecystectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CBDS risk	From diagnostic to surgery	Probability of CBDS presence at the moment of AC diagnose based on classification on risk modified from Maple et al. 2010: high, intermediate or low

Secondary Outcome Measures

Name	Time	Method
Postoperative morbidity	From surgery to 1 year	Adverse events (biliary fistula presence and ERCP (endoscopic retrograde cholangiopancreatography) requirements) identification during the postoperative period: Y/N
Readmission	From discharge to 1 year	Requirement of readmission after discharge
Intraoperative cholangiography	During the surgery	Percentage of patients who underwent intraoperative cholangiography (IOC) in each group: %