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

Overview

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.

Full Title of Study: “Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors for Its Diagnosis and Management”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: April 15, 2021

Detailed Description

Data will be obtained from the hospital (Consorci Sanitari del Maresme) clinical database. The Ethics Committee approval has been obtained.

Clinical Trial Outcome Measures

Primary Measures

  • CBDS risk
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥18 years Exclusion Criteria:

  • Non urgent cholecystectomy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital de Mataró
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ana Ciscar, General and digestive surgery specialist – Hospital de Mataró
  • Overall Contact(s)
    • Ana Ciscar, Mrs, 0034937417700, aciscar@casdm.cat

References

Pisano M, Allievi N, Gurusamy K, Borzellino G, Cimbanassi S, Boerna D, Coccolini F, Tufo A, Di Martino M, Leung J, Sartelli M, Ceresoli M, Maier RV, Poiasina E, De Angelis N, Magnone S, Fugazzola P, Paolillo C, Coimbra R, Di Saverio S, De Simone B, Weber DG, Sakakushev BE, Lucianetti A, Kirkpatrick AW, Fraga GP, Wani I, Biffl WL, Chiara O, Abu-Zidan F, Moore EE, Leppaniemi A, Kluger Y, Catena F, Ansaloni L. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020 Nov 5;15(1):61. doi: 10.1186/s13017-020-00336-x.

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