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SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis (SnapChole)

29 aprile 2026 aggiornato da: European Society for Trauma and Emergency Surgery

This study aims to understand how different treatment approaches for acute gallbladder inflammation (acute calculous cholecystitis) affect patient outcomes in real-world hospital settings.

Acute calculous cholecystitis is a common condition that occurs when gallstones block the gallbladder and cause infection or inflammation. In more severe cases, patients may develop organ dysfunction, and doctors must decide quickly how best to treat the condition. Treatment options include early surgery to remove the gallbladder, placement of a drainage tube, or treatment with antibiotics alone. The best approach is not always clear, especially for patients who are older, have other medical conditions, or are very unwell.

This study will collect information from hospitals around the world about how patients with severe gallbladder inflammation are treated as part of their usual care. No treatments are assigned by the study. All decisions are made by the patient's clinical team.

The goal is to compare outcomes between different treatment approaches in patients who could reasonably receive more than one option. The study will examine recovery, survival, need for additional procedures, and time spent in the hospital over 90 days.

The findings are intended to help doctors and patients better understand which treatment strategies may lead to better outcomes in different clinical situations, and to improve decision-making in emergency surgical care.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

SnapChole is an international, multicenter, prospective, time-bound observational platform study designed to evaluate management strategies and outcomes in adults with acute calculous cholecystitis. The study focuses on patients with severe disease, defined by the presence of organ dysfunction, in whom treatment decisions are influenced by both patient-level factors and system-level capability.

The study is conducted as a prospective clinical audit using routinely collected data and does not alter patient care. Participating centers enroll consecutive eligible patients during a predefined local accrual window. Data are recorded contemporaneously using standardized case report forms and transferred in deidentified form to a central coordinating database. Follow-up extends to 90 days from the index presentation.

The study architecture separates descriptive benchmarking from causal analysis. The full cohort provides a denominator population for characterization of treatment patterns, timing of interventions, and outcomes across centers and healthcare systems. Within this cohort, prespecified analytic subsets are defined at the point of clinical decision-making (time zero), corresponding to the moment at which the treating team determines that one or more management strategies are feasible.

Comparative analyses are structured to align eligibility, treatment assignment, and follow-up, consistent with a target trial emulation framework applied to observational data. Treatment strategies of interest include early cholecystectomy, gallbladder drainage as an initial approach, and antimicrobial-only management. Analyses are restricted to patients in whom the relevant strategies are simultaneously available, in order to reduce bias arising from differences in clinical eligibility or institutional capability.

Exposure is defined as completion of the assigned management strategy within a prespecified interval following the decision point, reflecting real-world delivery of care. Outcomes include days alive and out of hospital at 90 days, mortality, need for additional interventions, and time to achieved source control.

The study also incorporates complementary analyses, including benchmarking of care pathways, evaluation of patient-centered outcomes, and assessment of factors influencing clinical decision-making. Together, these components are intended to provide a comprehensive understanding of how management strategies are selected and how they relate to outcomes in severe acute calculous cholecystitis.

Tipo di studio

Osservativo

Iscrizione (Stimato)

1500

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adults with severe acute calculous cholecystitis (Tokyo Guidelines 2018 Grade III) presenting to participating centers and managed under routine clinical care. The population reflects patients in whom treatment decisions are influenced by physiologic severity, comorbidity, and institutional capability. Consecutive eligible patients are enrolled prospectively to define a real-world denominator cohort. Analytic subsets are subsequently defined at the attending surgeon-level decision point to evaluate treatment strategies under conditions in which alternative approaches are simultaneously feasible.

Descrizione

Inclusion Criteria:

  • Age ≥18 years
  • Presentation with suspected acute calculous cholecystitis
  • Diagnosis confirmed prospectively according to Tokyo Guidelines 2018 (TG18) diagnostic criteria
  • Classified as severe (TG18 Grade III) disease based on the presence of organ dysfunction
  • Managed at a participating center during the study accrual period

Exclusion Criteria:

  • Acalculous cholecystitis
  • Isolated choledocholithiasis or acute cholangitis without cholecystitis
  • Primary gallstone pancreatitis without concomitant acute cholecystitis
  • Elective admission for chronic biliary symptoms
  • Prior cholecystectomy

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Full Platform Cohort
Consecutive adult patients presenting with acute calculous cholecystitis and meeting Tokyo Guidelines 2018 diagnostic criteria, including those with severe (Grade III) disease. This cohort represents the full prospective denominator population and is used for benchmarking of treatment patterns, timing of interventions, and clinical outcomes under routine care. No restrictions are applied based on treatment strategy eligibility.
Dual-Eligible Cohort (Surgery vs Drainage)
Subset of patients with severe acute calculous cholecystitis (Tokyo Guidelines 2018 Grade III) in whom both early cholecystectomy and gallbladder drainage are judged feasible and available at the attending surgeon-level decision point (time zero). This cohort forms the analytic population for target trial emulation comparing operative source control with drainage-first strategies. Eligibility is defined prior to treatment assignment.
Nonoperative-Eligible Cohort (Drainage vs Antibiotics)
Subset of patients with severe acute calculous cholecystitis (Tokyo Guidelines 2018 Grade III) not selected for immediate surgery but in whom both drainage-first and antimicrobial-only management are feasible at the time of decision. This cohort forms the analytic population for target trial emulation comparing nonoperative management strategies. Eligibility is defined at time zero prior to treatment initiation.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Days alive and out of hospital at 90 days
Lasso di tempo: 90 days from time zero (attending surgeon-level decision point)
Number of days the participant is alive and not hospitalized during the 90 days following time zero, defined as the attending surgeon-level decision point at which treatment strategy is assigned. Higher values indicate better recovery.
90 days from time zero (attending surgeon-level decision point)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-cause mortality
Lasso di tempo: 90 days from time zero
Death from any cause within the specified follow-up period after time zero, defined as the attending surgeon-level decision point at which treatment strategy is assigned.
90 days from time zero
Failure of Source Control
Lasso di tempo: Within 90 days from time zero
Persistent or recurrent sepsis requiring escalation of intervention, including conversion to surgery, additional drainage procedures, or reoperation following the initial management strategy.
Within 90 days from time zero
Unplanned biliary reintervention
Lasso di tempo: within 90 days of time zero
Any unplanned procedural intervention related to biliary disease, including repeat drainage, operative intervention, or endoscopic procedures following the initial management strategy.
within 90 days of time zero
Length of hospital stay
Lasso di tempo: From hospital admission to hospital discharge, assessed up to 90 days from time zero
Total duration of the index hospital admission measured from admission to discharge.
From hospital admission to hospital discharge, assessed up to 90 days from time zero
Time to achieved source control
Lasso di tempo: From time zero to completion of source-control intervention, assessed up to 90 days
Elapsed time from time zero to completion of the definitive source-control intervention, including surgical or drainage procedures.
From time zero to completion of source-control intervention, assessed up to 90 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

European Society for Trauma and Emergency Surgery

Collaboratori

University of Pennsylvania

Investigatori

  • Cattedra di studio: Gary A Bass, MD, PhD, University of Pennsylvania

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

23 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SnapChole

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

Deidentified individual participant data are collected as part of a prospective international clinical audit and stored in a secure centralized database. Data sharing policies will be developed in accordance with applicable data protection regulations, including GDPR and HIPAA, and will be governed by the study steering committee. Requests for data access may be considered following publication of primary analyses, subject to institutional agreements and ethical approvals.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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