Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis

A Randomized Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis

Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after resolution of pain for mild gallstone pancreatitis.

The purpose of this study is to perform a single-center randomized trial to compare laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) within 24 hours of presentation versus after clinical resolution during index admission for mild gallstone pancreatitis on clinical and patient-reported outcomes. Additionally, this study aims to determine patients' values and preferences that influence decision-making regarding treatment options for gallstone pancreatitis. Hypothesis: During index admission for mild gallstone pancreatitis, early cholecystectomy within 24 hours of presentation regardless of symptoms or laboratory values versus after clinical resolution results in a shorter 30-day total hospital length of stay.

Inclusion Criteria:

• Diagnosis of gallstone pancreatitis. Patients will be considered to have gallstone pancreatitis if they have:

  1. upper abdominal pain, nausea, vomiting, and epigastric tenderness
  2. absence of ethanol abuse
  3. elevated lipase level above the upper limit of normal (>370 U/L)
  4. imaging confirmation of gallstones or sludge

• Low predicted mortality using the Bedside Index of Severity in Acute Pancreatitis (BISAP) -Diagnosis of mild pancreatitis (i.e.,no evidence of organ failure or local or systemic complications)

• Scheduled for laparoscopic cholecystectomy prior to discharge

• Lack of any very strong indicator for choledocholithiasis based on the American Society for Gastrointestinal Endoscopy (ASGE) guidelines

• Clinical stability as denoted by admission to a non-monitored floor bed.

Exclusion criteria

• Pregnancy
• Severe preexisting medical comorbidities precluding surgery, organ failure, local or systemic complications of acute pancreatitis
• Chronic pancreatitis
• Native language other than English and Spanish
• Patient refusal to participate