Validation of a scoring system to predict mortality after gallbladder surgery for acute cholecystitis
Official title: CHOLE-POSSUM PRO Validation for Prediction of Mortality After Cholecystectomy for Acute Calculous Cholecystitis: Protocol for a Prospective Multicenter Observational Study
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT06908980 · Data updated 2026-11-12
This study is testing a new scoring system to see if it can help predict the risk of death within 30 days after gallbladder surgery for people with acute cholecystitis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2500 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | October 11, 2025 |
| Study ends | October 11, 2025 |
| Registry record updated | April 3, 2025 |
| Trial ID | NCT06908980 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults diagnosed with acute calculous cholecystitis who are eligible for early cholecystectomy.
✕Probably not a fit
Patients who are pregnant, have acute cholecystitis not related to gallstones, or have had symptoms for more than 10 days prior to surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to validate the CHOLE-POSSUM PRO SCORE, which predicts 30-day mortality in patients diagnosed with acute calculous cholecystitis who are candidates for early cholecystectomy. The study will involve multiple centers and will include patients who meet specific inclusion criteria, such as being over 18 years old and having a confirmed diagnosis of acute calculous cholecystitis. Participants will be monitored for their outcomes following surgery to assess the accuracy of the scoring system.
Why it matters
Potential benefit: If successful, this study could improve risk assessment and management strategies for patients undergoing gallbladder surgery, potentially reducing mortality rates.
How similar studies have gone: While the CHOLE-POSSUM PRO SCORE is being validated in this study, similar scoring systems have shown promise in predicting surgical outcomes in other contexts.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy Recruiting
Study contacts
- Study coordinator: Luca Ansaloni, MD
- Email: l.ansaloni@smatteo.pv.it
- Phone: +39 0382 50 2530
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.