Abstract

The American Society for Gastrointestinal Endoscopy (ASGE) 2010 guidelines for suspected choledocholithiasis were recently updated by proposing more specific criteria for selection of high-risk patients while advocating for using noninvasive studies for intermediate and low risk individuals. Both guidelines recommend direct endoscopic retrograde cholangiopancreatography (ERCP) for ascending cholangitis and choledocholithiasis on imaging. As per 2010 guidelines, total bilirubin > 4 mg/dl and total bilirubin between 1.8 to 4 mg/dl along with dilated bile duct on imaging met criteria for direct ERCP. In 2019 guideline, this was changed to total bilirubin > 4 mg/dl in combination with CBD dilation > 6 mm as an indication for direct ERCP. We aim to compare the performance and diagnostic accuracy of 2019 vs 2010 criteria for predicting choledocholithiasis. From a prospectively maintained database (2013 to 2019) of over 10,000 ERCPs performed by 70 Gastroenterologist’s in our hospital system comprising of 14 hospitals, a random sample of 1400 ERCPs with indication of choledocholithiasis was selected. Data regarding demographics, total bilirubin level, imaging studies such as abdominal ultrasound, computed tomography of abdomen or magnetic resonance cholangiopancreatography (MRCP), Intraoperative cholangiogram (IOC), Endoscopic ultrasound (EUS) and ERCP results were retrospectively collected by chart review. Patients with prior sphincterotomy were excluded. From a random sample of 1400 ERCPs, 843 patients had native papilla and were included in the study. Both 2010 and 2019 guidelines were applied to the same patient population. Overall, 61.2% (518) were deemed high risk and met criteria for direct ERCP as per 2010 guidelines compared to only 37.7% (318) as per revised 2019 guidelines. This difference of 200 patients (24%) was statistically significant as per z statistics comparing two population proportions (p value < 0.001). Choledocholithiasis were found at ERCP in 76.5% (395/518) as per 2010 guidelines, compared to 82.1% (261/318) of those who met the 2019 high risk criteria. Once again, this difference (76.5% vs 82.07%, respectively) was statistically significant (p value < 0.001). In our patient cohort, overall specificity of 2010 guidelines was 46.9% and this improved to 75.0% as per 2019 criteria (Table 1). Our study shows that the strategy proposed by updated 2019 ASGE guidelines is more specific for detection of choledocholithiasis when compared to the 2010 criteria. These findings suggest adherence to the new guidelines would potentially minimizes the procedure adverse events for those individuals who do not meet the high-risk criteria.

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