NCT06228027

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jan 2025Apr 2027

First Submitted

Initial submission to the registry

January 18, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2027

Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

January 18, 2024

Last Update Submit

March 7, 2024

Conditions

Acute Cholecystitis

Keywords

Acute CholecystitisCholecystectomyTokyo GuidelinesPostoperative ComplicationsMortalityHigh-risk patient

Outcome Measures

Primary Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Acute Calculous Cholecystitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholecystitis, AcutePostoperative Complications

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ana María González Castillo, PhD

    Hospital del Mar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana María González Castillo, PhD

CONTACT

+34665126866amgonzalezcastillo@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 29, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 15, 2027

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share