Uncomplicated Choledocholithiasis in Elderly Patients: A Target Trial Emulation Comparing Observation and Endoscopic Retrograde Cholangiopancreatography.

BACKGROUND & AIMS: The management of uncomplicated choledocholithiasis in elderly patients remains controversial due to uncertain clinical benefits of intervention and higher complication rates with endoscopic retrograde cholangiopancreatography (ERCP). We emulated a target trial comparing early ERCP vs observation in elderly patients with uncomplicated choledocholithiasis.

METHODS

Target trial emulation using health record data from TriNetX. Patients >75 years with an incident choledocholithiasis diagnosis between 2015 and 2023 were included. The ERCP group underwent ERCP within 60 days of Time Zero; the observation group did not. Cohorts were constructed with propensity score matching. The primary outcome was a composite of major adverse events within 3 years or all-cause mortality within 12 months. Adjusted Cox regression was performed to compare the survival outcome between groups. Win ratio was calculated for reporting the hierarchical composite outcome. Sensitivity analyses were conducted with a 30-day ERCP window and patients diagnosed at ambulatory encounter only.

RESULTS

Among 5856 matched patients (2928 per group), the composite outcome occurred in 30.7% of ERCP vs 22.4% of observation patients; however, there was no significant difference (adjusted hazard ratio [aHR], 1.13; 95% confidence interval [CI], 0.99-1.28). The win ratio favored observation (0.71; 95% CI, 0.64-0.79). In both sensitivity analyses, ERCP was associated with higher major adverse events (30-day ERCP window: aHR, 1.14; 95% CI, 1.00-1.31; ambulatory-only: aHR, 1.61; 95% CI, 1.13-2.29). Mortality did not differ significantly.

CONCLUSIONS

In elderly patients with uncomplicated choledocholithiasis, early ERCP was not associated with improved outcomes. Findings support a selective, 'as-needed' approach to ERCP in this population.