Skip to main content
Clinical Trials/NCT04739891
NCT04739891
Unknown
Not Applicable

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

Hospital de Mataró0 sites120 target enrollmentFebruary 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Cholecystitis
Sponsor
Hospital de Mataró
Enrollment
120
Primary Endpoint
CBDS risk
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2021
End Date
April 15, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital de Mataró
Responsible Party
Principal Investigator
Principal Investigator

Ana Ciscar

General and digestive surgery specialist

Hospital de Mataró

Eligibility Criteria

Inclusion Criteria

  • Age ≥18 years

Exclusion Criteria

  • Non urgent cholecystectomy

Outcomes

Primary Outcomes

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 Outcomes

  • Postoperative morbidity(From surgery to 1 year)
  • Readmission(From discharge to 1 year)
  • Intraoperative cholangiography(During the surgery)

Similar Trials