Real-World Early and Short-Term Outcomes of ERCP-Guided Biliary Stenting in Suspected Malignant or Indeterminate Biliary Strictures

Background and Objectives: Biliary strictures considered malignant or indeterminate at the time of endoscopic retrograde cholangiopancreatography (ERCP) frequently require endoscopic biliary drainage for biochemical improvement, symptom control, and continuation of diagnostic or oncologic management. This study aimed to evaluate the early and short-term real-world outcomes of ERCP-guided biliary stenting in patients with biliary strictures considered malignant or indeterminate at the time of ERCP, including cases in which malignancy was not subsequently confirmed. Materials and Methods: This single-center retrospective observational study screened 996 analyzable ERCP records performed between 27 February 2024 and 27 April 2026. The final cohort included 164 ERCP-guided biliary stenting procedures performed in 162 patients with suspected malignant or indeterminate biliary strictures. Clinical drainage success was defined according to the treating endoscopist’s documented assessment based on clinical improvement and/or biochemical bilirubin decline after stenting. Results: The median age was 60.0 years, and 87 procedures (53.0%) were performed in female patients. Definite malignancy was documented in 121 cases (73.8%). Distal strictures were the most common localization (72.0%). Clinical drainage success was achieved in 153 cases (93.3%). Median total bilirubin decreased from 1.50 mg/dL before ERCP to 0.42 mg/dL on post-ERCP day 14 (p < 0.001). ERCP-related adverse events occurred in 18 cases (11.0%), including post-ERCP pancreatitis in 10 cases (6.1%). Thirty-day mortality occurred in 2 cases (1.2%). Stent dysfunction and repeat ERCP were each observed in 23 cases (14.0%). Using a pre-ERCP total bilirubin threshold of >3.0 mg/dL, jaundice at presentation was present in 61 procedures (37.2%). Clinical drainage success was 91.8% in jaundiced procedures and 94.2% in non-jaundiced procedures. In a restricted multivariable model including only ASA physical status ≥3 and stent type, ASA physical status ≥3 showed an exploratory association with stent dysfunction (adjusted odds ratio: 4.84; 95% confidence interval: 1.36–17.23; p = 0.015). Although adverse event rates differed between plastic and metal stent groups, these comparisons were limited by baseline imbalance. Conclusions: ERCP-guided biliary stenting provided high clinical drainage success and significant early bilirubin reduction in patients with suspected malignant or indeterminate biliary strictures. Subgroup analyses suggested that stricture localization influenced real-world stent selection, whereas clinical drainage success and stent dysfunction did not differ significantly between distal and perihilar/hilar strictures. Stent dysfunction and repeat ERCP were required in a minority of cases, and higher ASA physical status showed an exploratory association with stent dysfunction, but this finding should be interpreted cautiously because of the limited number of dysfunction events. Stent-type comparisons should be interpreted cautiously because of real-world selection bias.