Recruiting NCT06908980
CHOLE-POSSUM PRO Validation for Prediction of Mortality After Cholecystectomy for Acute Calculous Cholecystitis: Protocol for a Prospective Multicenter Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Calculous Cholecystitis Candidate to Early Cholecystectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- The AUC-ROC for 30-days mortality computed in the validating cohort [Time frame: Day 30]
Secondary outcome measures (1)
- The AUC-ROC for 30-days major complications (Clavien-Dindo ≥3) rate computed in the validating cohort [Time frame: Day 30]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- Fondazione IRCCS Policlinico San Matteo — Pavia
Identifiers
NCT: NCT06908980 · CHOLE-POSSUM PRO