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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04739891

Acronym

CHOLEPREV

Enrollment

120

Registered

2021-02-05

Start date

2021-02-15

Completion date

2021-04-15

Last updated

2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cholecystitis, Choledocholithiasis

Keywords

Acute Cholecystitis, Choledocholithiasis, Urgent cholecystectomy, Risk factors

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Age ≥18 years

Exclusion criteria

* Non urgent cholecystectomy

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Intraoperative cholangiography	During the surgery	Percentage of patients who underwent intraoperative cholangiography (IOC) in each group: %
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

Contacts

Primary ContactAna Ciscar, Mrs

aciscar@casdm.cat0034937417700

Backup ContactMarina Vila, Mrs

mvilatu@csdm.cat0034937417700

Outcome results