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NCT06228027 Clinical Trial

External Validation os the ACME Scoring System

Acute Cholecystitis Clinical Trial

— ACME_2  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06228027
Other study ID # External_ACME Validation
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2025
Est. completion date April 15, 2027

Study information
Verified date March 2024
Source Hospital del Mar
Contact Ana María González Castillo, PhD
Phone +34665126866
Email amgonzalezcastillo@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10000
Est. completion date April 15, 2027
Est. primary completion date January 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Acute Calculous Cholecystitis Exclusion Criteria: - Acute Cholangitis - Chronic Cholecystitis - Neoplasia - Acute Pancreatitis - Pregnant

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital del Mar

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