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.
Age ≥18 years
Presentation with suspected acute calculous cholecystitis
Diagnosis confirmed prospectively according to Tokyo Guidelines 2018 (TG18) diagnostic criteria
Classified as moderate (Tokyo Guidelines 2018 [TG18] Grade II) or severe (TG18 Grade III) acute cholecystitis according to TG18 severity criteria; Grade III disease is defined by organ dysfunction.
Acalculous cholecystitis
Isolated choledocholithiasis or acute cholangitis without cholecystitis
Primary gallstone pancreatitis without concomitant acute cholecystitis
Elective admission for chronic biliary symptoms
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.
Cohort
Prospective
Not listed
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.
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.
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.
Unplanned biliary reintervention
Any unplanned procedural intervention related to biliary disease, including repeat drainage, operative intervention, or endoscopic procedures following the initial management strategy.
Length of hospital stay
Total duration of the index hospital admission measured from admission to discharge.
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European Society for Trauma and Emergency Surgery
Lead sponsor
University of Pennsylvania
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
