Actively Recruiting

Age: 18Years +
All Genders
NCT06908980

CHOLE-POSSUM PRO Validation for Prediction of Mortality After Cholecystectomy for Acute Calculous Cholecystitis: Protocol for a Prospective Multicenter Observational Study

Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-04-03

2500

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

CHOLE-POSSUM PRO Validation for Prediction of Mortality After Cholecystectomy for Acute Calculous Cholecystitis: Protocol for a Prospective Multicenter Observational Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of acute calculous cholecystitis as defined by TG18 criteria
  • Candidate for early cholecystectomy during the initial hospital admission, including open cholecystectomy, early laparoscopic cholecystectomy, conversions, or bail-out procedures
  • Age 18 years or older
  • Stratified for risk of common bile duct stones using the Israelian Score and, if confirmed, received pre-operative ERCP
  • Provided signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the study duration
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation
  • Acute cholecystitis not caused by gallstones
  • Symptoms started more than 10 days before cholecystectomy (except if pre-operative ERCP done and EC within 10 days)
  • Presence of pancreatitis
  • Intraoperative treatment of common bile duct stones
  • Any condition that increases risk or prevents full compliance or study completion

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, Italy, 27100

Actively Recruiting

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Research Team

L

Luca Ansaloni, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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CHOLE-POSSUM PRO Validation for Prediction of Mortality After Cholecystectomy for Acute Calculous Cholecystitis: Protocol for a Prospective Multicenter Observational Study | DecenTrialz