Colelitiasis no complicada en pacientes ancianos: Emulación de un ensayo dirigido para comparar la observación y la...

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 versus observation in elderly patients with uncomplicated choledocholithiasis.

Target trial emulation using health record data from TriNetX. Patients >75 years with an incident choledocholithiasis diagnosis between 2015-2023 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.

Among 5,856 matched patients (2,928 per group), the composite outcome occurred in 30.7% of ERCP versus 22.4% of observation patients, however, there was no significant difference (aHR 1.13; 95% 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 MAE (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.

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.