Outcomes and predictors in biliary drainage strategies: comparing ERCP and EUS-BD after ERCP failure in biliary malignant distal obstruction

Aims Endoscopic Retrograde Cholangio-Pancreatography (ERCP) is the gold standard for biliary drainage in both benign and malignant stenosis. Sometimes the procedure may fail due to the presence of altered anatomy (bariatric surgery and resective surgery), inaccessible papilla (malignant obstruction) and cannulation failure (diverticulum, papilla infiltration). This study aims to identify a target group of patients with malignant distal obstruction (MDO) in whom EUS-BD might be applicable as a first-choice procedure. The second goal is to evaluate whether there are clinical differences between patients drained by ERCP and those drained by EUS-BD after ERCP failure; the third one is to identify differences on the occurrence of complications according to the strategy adopted; finally, the fourth goal is to search for positive or negative predictors in evaluating clinical efficacy/failure.

Methods This is a single referral tertiary centre retrospective cohort study conducted between January 2019 and June 2024. Data of 181 patients undergoing a biliary drainage procedure (ERCP or ERCP+EUS-BD) for MDO have been collected.

Results The median age at the procedure was 75 years, at death was 76 years and the median survival was 8.13 months. A successful ERCP drainage was obtained in 144 patients while 37 were drained by EUS-BD after ERCP failure. Age at procedure and survival in month were found to be statistically significantly associated with the type of strategy used (ERCP vs ERCP+EUS-BD) respectively with a p-value of 0.044 and p<0.01. In particular, the ERCP+EUS-BD group identified a frailer group of patients: older and with lower survival rate. The survival curve for strategy, based on Kaplan-Meier analysis, confirms in our series a trend toward lower survival in the ERCP+EUS-BD group with Log-rank p-value 0.06 (threshold p-value 0.1). There were no statistically significant differences between the two groups regarding the occurrence of post-procedure complications. We performed a univariate logistic regression model for total bilirubin two weeks after the procedure suggesting that bilirubin might be a negative predictor of clinical success (p-value<0.01, OR 0.832) with high sensitivity (0.986) and precision (0.844), but a low specificity (0.286).

Conclusions EUS-BD has a broad potential in the clinical-therapeutic management of MDO. It can be complementary to ERCP simplifying the procedure and, in selected cases, could even replace it. Our study showed, in the cohort undergoing echo-endoscopic drainage when ERCP failed, a frailer group of patients. In these subset of patients EUS-BD could be considered as the procedure of choice according to intrinsic factors of the tumor (size, location, papilla infiltration). This approach would give the possibility to perform personalized medicine to decrease complications related to ERCP or long deep sedation.

Publication History

Article published online:
27 March 2025