External Validation os the ACME Scoring System (ACME_2)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Cholecystitis

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Ana María González Castillo, PhD; Phone Number: +34665126866; Email: amgonzalezcastillo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All the consecutive admisions with an acute calculous cholecystitis, independent on the treatment indicated, during 2025 and 2026.

Description

Inclusion Criteria:

• Acute Calculous Cholecystitis

Exclusion Criteria:

• Acute Cholangitis
• Chronic Cholecystitis
• Neoplasia
• Acute Pancreatitis
• Pregnant

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital del Mar
• Investigators: Principal Investigator: Ana María González Castillo, PhD, Hospital Del Mar

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mortality; Cholecystectomy; Postoperative Complications; Acute Cholecystitis; Tokyo Guidelines; High-risk patient
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: External_ACME Validation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No