Status:
RECRUITING
CHOLE-POSSUM PRO Validation for Prediction of Mortality After Cholecystectomy for Acute Calculous Cholecystitis: Protocol for a Prospective Multicenter Observational Study
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Acute Calculous Cholecystitis Candidate to Early Cholecystectomy
Eligibility:
All Genders
18+ years
Brief Summary
CHOLE-POSSUM PRO is a prospective multicenter observational study on patients with ACC candidate to EC. The rationale of the study is to validate the CHOLE-POSSUM PRO SCORE for 30-day mortality in thi...
Eligibility Criteria
Inclusion
- have a diagnosis of ACC as defined by TG18 criteria
- be ACC candidate to EC during the index admission\* (\* All the patients treated with initial open cholecystectomy, those who undergo ELC, those with conversion from laparoscopic to open cholecystectomy or those who undergo bail out procedures (e.g. subtotal cholecystectomy) will be included.)
- be ≥ 18 years old
- be stratified for the risk of CBDS according to the Israelian Score (29), and, in case of confirmation of CBDS receive pre-operative ERCP
- provide signed and dated informed consent form
- willing to comply with all study procedures and be available for the duration of the study.
Exclusion
- pregnancy or lactation
- acute cholecystitis not related to a gallstone etiology
- onset of symptoms \>10 days before cholecystectomy\*\* (\*\* Patients with ACC associated with common bile duct stones who underwent pre-operative ERCP could be included if they receive EC within 10 days from onset of symptoms)
- concomitant pancreatitis
- intraoperative treatment of common bile duct stones
- anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 11 2025
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT06908980
Start Date
March 1 2024
End Date
October 11 2025
Last Update
April 3 2025
Active Locations (1)
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1
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy, 27100