Protocol for a randomized trial of the effect of timing of cholecystectomy during initial admission for predicted mild gallstone pancreatitis at a safety-net hospital

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Figure 1
Schedule of enrollment, interventions, and assessments.

Table 1

International, consensus-based definitions of severity of acute pancreatitis

Severity	Definition
Mild	No organ failure, local or systemic complications and usually resolves in first week
Moderate	Transient organ failure, local complications or exacerbation of comorbid disease
Severe	Persistent organ failure (>48 hours)

Local complications include peripancreatic fluid collections, pancreatic and peripancreatic necrosis (sterile or infected), pseudocyst, and walled-off necrosis.19

Table 2

American Society for Gastrointestinal Endoscopy (ASGE) guidelines

Likelihood	Predictors
Very strong	Common bile duct stone on transabdominal ultrasound
	Clinical ascending cholangitis
	Bilirubin >4 mg/dL
Strong	Dilated common bile duct (>6 mm) on ultrasound
Strong	Bilirubin level 1.8–4 mg/dL
Moderate	Abnormal liver biochemical test other than bilirubin
	Age older than 55 years
	Clinical gallstone pancreatitis

Presence of any strong or both strong predictors suggests a high likelihood of choledocholithiasis. No predictors suggest a low likelihood, and all other patients have an intermediate likelihood.18 By definition, all patients enrolled in this trial will have at least a moderate likelihood because of the clinical diagnosis of gallstone pancreatitis.