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

Conditions

• Cholecystitis, Acute

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Aug 1, 2026

Status verified

Apr 2026

Primary completion

Aug 1, 2027

Completion

Jan 1, 2028

Study Design

Enrollment

1,500 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Days alive and out of hospital at 90 days [ Time Frame: 90 days from time zero (attending surgeon-level decision point) ]

Central Contacts

• Gary A Bass, MD, PhD
  2672168309
  [email protected]
• Stefano PB Cioffi, MD, PhD
  2672168309
  [email protected]

Locations (1)

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