An observational study in Cholecystitis, Acute, sponsored by European Society for Trauma and Emergency Surgery. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by European Society for Trauma and Emergency Surgery · Observational
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.
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.
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 216 across 52 observational studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →European Society for Trauma and Emergency Surgery is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 1, 2026. See what changed
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Consecutive adult patients presenting with acute calculous cholecystitis and meeting Tokyo Guidelines 2018 diagnostic criteria, including those with moderate (Grade II) and 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.
Subset of patients with moderate/severe acute calculous cholecystitis (Tokyo Guidelines 2018 Grades II and 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.
Subset of patients with moderate/severe acute calculous cholecystitis (Tokyo Guidelines 2018 Grades II and 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.
Days alive and out of hospital at 90 days
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.
Time frame: 90 days from time zero (attending surgeon-level decision point)
All-cause mortality
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.
Time frame: 90 days from time zero
Failure of Source Control
Persistent or recurrent sepsis requiring escalation of intervention, including conversion to surgery, additional drainage procedures, or reoperation following the initial management strategy.
Time frame: Within 90 days from time zero
Unplanned biliary reintervention
Any unplanned procedural intervention related to biliary disease, including repeat drainage, operative intervention, or endoscopic procedures following the initial management strategy.
Time frame: within 90 days of time zero
Length of hospital stay
Total duration of the index hospital admission measured from admission to discharge.
Time frame: From hospital admission to hospital discharge, assessed up to 90 days from time zero
Time to achieved source control
Elapsed time from time zero to completion of the definitive source-control intervention, including surgical or drainage procedures.
Time frame: From time zero to completion of source-control intervention, assessed up to 90 days
Plan to share: Undecided — 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.
Start is estimated for Jan 2027; primary completion for Aug 2027, 7 months later.
Of 22 observational studies under Cholecystitis, Acute, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's planned 7 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Jan 2027, on Oct 1, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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European Society for Trauma and Emergency Surgery