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

April 1, 2025 updated by: Luca Ansaloni, Fondazione IRCCS Policlinico San Matteo di Pavia
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients who receive a diagnosis of ACC as defined by TG18 criteria and with ACC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The AUC-ROC for 30-days mortality computed in the validating cohort
Time Frame: Day 30
Day 30

Secondary Outcome Measures

Outcome Measure
Time Frame
The AUC-ROC for 30-days major complications (Clavien-Dindo ≥3) rate computed in the validating cohort
Time Frame: Day 30
Day 30

Other Outcome Measures

Outcome Measure
Time Frame
Intraoperative complications rate
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
Duration of surgery
Time Frame: immediately after the surgery
immediately after the surgery
Conversion rate
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
Length of stay (LOS)
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
30-days readmission rate
Time Frame: Day 30
Day 30
Result of blood and bile cultures
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

October 11, 2025

Study Completion (Estimated)

October 11, 2025

Study Registration Dates

First Submitted

March 22, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHOLE-POSSUM PRO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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