External Validation os the ACME Scoring System

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06228027

Acronym

ACME_2

Enrollment

10000

Registered

2024-01-29

Start date

2025-01-01

Completion date

2027-04-15

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cholecystitis

Keywords

Acute Cholecystitis, Cholecystectomy, Tokyo Guidelines, Postoperative Complications, Mortality, High-risk patient

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Acute Calculous Cholecystitis

Exclusion criteria

* Acute Cholangitis * Chronic Cholecystitis * Neoplasia * Acute Pancreatitis * Pregnant

Design outcomes

Primary

Measure	Time frame	Description
Mortality	Jan 2025- Dec 2026	Describe the mortality in the cohort and its causes
Complications	Jan 2025- Dec 2026	Describe the mortality in the cohort by Clavien-Dindo's classification
ACME's prediction of mortality	Jan 2025- Dec 2026	To describe the prediction in a ROC Curve of ACME Scoring System with C-Statistic

Contacts

Primary ContactAna María González Castillo, PhD

amgonzalezcastillo@gmail.com+34665126866

Outcome results