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Recruiting

NCT Number: NCT06908980

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The AUC-ROC for 30-days mortality computed in the validating cohort

    Time frame: Day 30

Secondary outcomes

  1. The AUC-ROC for 30-days major complications (Clavien-Dindo ≥3) rate computed in the validating cohort

    Time frame: Day 30

Other outcomes

  1. Intraoperative complications rate

    Time frame: through study completion, an average of 2 years

  2. Duration of surgery

    Time frame: immediately after the surgery

  3. Conversion rate

    Time frame: through study completion, an average of 2 years

  4. Length of stay (LOS)

    Time frame: through study completion, an average of 2 years

  5. 30-days readmission rate

    Time frame: Day 30

  6. Result of blood and bile cultures

    Time frame: Day 0

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Ansaloni, MD

CONTACT

[email protected]

+39 0382 50 2530

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.