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

Choledocholithiasis Clinical Trial

— CHOLEPREV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04739891
• Other study ID #: CHOLEPREV2021
• Status: Not yet recruiting
• Start date: February 15, 2021
• Est. completion date: April 15, 2021

Study information

• Verified date: February 2021
• Source: Hospital de Mataró
• Contact: Ana Ciscar, Mrs
• Phone: 0034937417700
• Email: aciscar[@]casdm.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

The Ethics Committee approval has been obtained.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age =18 years

Exclusion Criteria:

• Non urgent cholecystectomy

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute
• Choledocholithiasis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Mataró

References & Publications (1)

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, Leppäniemi 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CBDS risk	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	From diagnostic to surgery
Secondary	Intraoperative cholangiography	Percentage of patients who underwent intraoperative cholangiography (IOC) in each group: %	During the surgery
Secondary	Postoperative morbidity	Adverse events (biliary fistula presence and ERCP (endoscopic retrograde cholangiopancreatography) requirements) identification during the postoperative period: Y/N	From surgery to 1 year
Secondary	Readmission	Requirement of readmission after discharge	From discharge to 1 year