Prospective assessment of consensus criteria for evaluation of patients with suspected choledocholithiasis.

Background And Aim: American Society for Gastrointestinal Endoscopy (ASGE) guidelines have proposed criteria to stratify patients into low, intermediate and high risk of choledocholithiasis. The criteria include variables that are readily available in clinical practice. The objective of the present study was to prospectively assess the accuracy of these criteria.

Methods: A prospective observational cohort study was conducted at Beth Israel Deaconess Medical Center. All adult patients referred for endoscopic retrograde cholangiopancreatography (ERCP) with suspected choledocholithiasis were considered for inclusion. ASGE criteria were applied, and each patient was categorized as high, intermediate or low risk for choledocholithiasis. Presence of stone at ERCP served as criteria standard.

Results: During the study period, 402 patients met study inclusion criteria and 336 were reported in the final analysis. Of the 244 patients in the high risk for choledocholithiasis group, 185 were found to have stones at ERCP (75.8%, 95% CI 70.2-80.1%). Of the 92 patients in the intermediate risk for choledocholithiasis group, 45 had stones at ERCP (48.9%, 95% CI 38.8-59.1%); P-value for difference between groups = 0.001. Diagnostic accuracy for choledocholithiasis in the high-risk group was 69.05%, and for the intermediate group was 39.95%. Presence of choledocholithiasis on pre-ERCP imaging (OR: 3.6; 95% CI 2.2-6.0; P < 0.01), and bilirubin >1.8 but <4 mg/dL (OR: 1.69; 95% CI 1.0-2.8; P < 0.04) were the strongest predictors of choledocholithiasis. No additional variable that improved accuracy of ASGE criteria was identified.

Conclusion: ASGE criteria stratify patients by risk for choledocholithiasis and can be used in routine clinical practice.