About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Acalculous cholecystitis
Isolated choledocholithiasis or acute cholangitis without cholecystitis
Primary gallstone pancreatitis without concomitant acute cholecystitis
Elective admission for chronic biliary symptoms
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
European Society for Trauma and Emergency Surgery
Lead sponsor
University of Pennsylvania
Collaborator