External Validation os the ACME Scoring System

Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is surgical treatment (ST) and the accepted mortality is <1%, but in severe and/or fragile patients is higher. Despite the Tokyo Guidelines, there no consensus on who is the unfit patient for ST. A recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (ACME) and could help to develop new guidelines in ACC. The aim of this study is to perfom an external validation of the new simplified scoring system for mortality in ACC.

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is a prospective multicenter observational study of 10.000 adults with ACC during 2 consecutive years (2025/2026), including baseline demographic characteristics, comorbidity severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines severity classification and the new ACME Scoring system. The primary outcome is to study the prediction of mortality of ACME score. Secondary outcomes include complications following Clavien-Dindo's classification, C-statistic, and ROC Curves.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Acute Calculous Cholecystitis

Exclusion criteria

Acute Cholangitis
Chronic Cholecystitis
Neoplasia
Acute Pancreatitis
Pregnant

Treatment and study plan

Primary outcomes

Mortality

Time frame: Jan 2025- Dec 2026

Describe the mortality in the cohort and its causes
Complications

Time frame: Jan 2025- Dec 2026

Describe the mortality in the cohort by Clavien-Dindo's classification
ACME's prediction of mortality

Time frame: Jan 2025- Dec 2026

To describe the prediction in a ROC Curve of ACME Scoring System with C-Statistic

Study contacts

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

Ana María González Castillo, PhD

CONTACT

[email protected]

+34665126866

Sponsors and collaborators

Lead sponsor

Hospital del Mar

Other

Registry information

Official study title

Prediction of the Mortality in Acute Calculous Cholecystitis. The ACME Project.

Acronym: ACME_2

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jan 29, 2024
Registry last updated: Mar 12, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed