Clinical trial NCT06908980: CHOLE-POSSUM PRO Validation for Prediction of Mortality After Cholecystectomy for Acute Calculous Cholecystitis: Protocol for a Prospective Multicenter Observational Study
Official title: CHOLE-POSSUM PRO Validation for Prediction of Mortality After Cholecystectomy for Acute Calculous Cholecystitis: Protocol for a Prospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Calculous Cholecystitis Candidate to Early Cholecystectomy
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive a diagnosis of ACC as defined by TG18 criteria and with ACC candidate to EC during the index admission

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 this population.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The AUC-ROC for 30-days mortality computed in the validating cohort
timeFrame: Day 30
Secondary outcomes:
measure: The AUC-ROC for 30-days major complications (Clavien-Dindo ≥3) rate computed in the validating cohort
timeFrame: Day 30
Other outcomes:
measure: Intraoperative complications rate
timeFrame: through study completion, an average of 2 years
measure: Duration of surgery
timeFrame: immediately after the surgery
measure: Conversion rate
timeFrame: through study completion, an average of 2 years
measure: Length of stay (LOS)
timeFrame: through study completion, an average of 2 years
measure: 30-days readmission rate
timeFrame: Day 30
measure: Result of blood and bile cultures
timeFrame: Day 0
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
References: