The European Society of Gastrointestinal Endoscopy (ESGE) recommend palliative stenting for patients with malignant distal biliary obstruction who are not candidates for oncologic treatment¹. The impact on survival and resolution of jaundice in this palliative population is scarce². The available techniques include Endoscopic Retrograde Cholangiopancreatography (ERCP), Endoscopic Ultrasound (EUS)- guided drainage, and percutaneous drainage. We aimed to assess the clinical outcomes of palliative biliary stenting in our cohort of patients with incurable distal biliary malignant obstruction.

We retrospectively analysed patients with distal malignant biliary obstruction between January 2023 and December 2024 who were unfit for surgery or oncologic therapy and presented with jaundice. Data collected included demographics, comorbidities, tumour characteristics, serology, pre- and post-drainage symptoms, and drainage technique. Complications within 30 days (post-ERCP pancreatitis (PEP), cholangitis, upper gastrointestinal bleed (UGIB), perforation) were recorded.

The primary endpoint was survival (weeks) comparing drained patients to those receiving best supportive care only. Secondary endpoints were ERCP technical and clinical success, need for additional procedures, complication rates, and independent predictors of mortality. Categorical and continuous variables were compared with Chi-square/Fisher and Mann-Whitney/Wilcoxon tests. Survival used Kaplan-Meier and Cox regression; p < 0.05.

The final sample included 56 patients (33 females, 58.9%) with a median age of 81 years (range 46–94). Most had moderate comorbidity: 39 (66.6%) were ASA (American Society of Anaesthesiologists) 1–2, and 17 (30.4%) were ASA 3. Performance status was 1–2 in 39 patients (69.6%) and 3 in 17 (30.4%). Regarding TNM stage at diagnosis, 15 patients (26.9%) were stage 0–I, 14 (25%) stage III, and 24 (42.9%) stage IV.

Overall, biliary drainage (BD) was successful in 42 patients (75%). ERCP was attempted in 46 (82.1%) and was successful in 40 (86.9%), with three requiring up to three sessions. Two underwent alternative techniques after failed ERCP (one EUS-guided, one percutaneous).  Complications occurred in 7 patients (12.5%): 1 PEP, 5 cholangitis, and 1 UGIB. The 30-day mortality in the drainage group was 23.8% (10 patients). There was no association with a complication. All had advanced TNM stage, which was statistically significant (p = 0.016).

Drainage significantly relieved symptoms: jaundice decreased from 97.6% to 33.3% (p = 0.001), pruritus from 40.5% to 9.5% (p < 0.001), and dyspepsia from 69% to 42.9% (p = 0.021), while pain remained unchanged (64.3%, p = 1.000). Bilirubin levels decreased significantly overall and when stratified by tumour stage (Median 212 vs 55, p= 0.001).

Patients without BD were older than those with BD (p = 0.04). Early TNM stage patients (0–2) were more frequently drained (93%) than advanced stage (3–4; 68%), showing a trend toward access to drainage in early disease (p = 0.058). No other differences in gender, comorbidities, serologic markers, or performance status were observed.

Overall, the median survival was 11 weeks (range 0–56). Patients with successful BD had higher median survival (14 vs 7 weeks) without reaching statistical significance (p = 0.370). Survival was significantly longer in early TNM stages (0–2) compared to advanced TNM (3–4) (median 28 vs 6 weeks, p = 0.008). In multivariate analysis, advanced TNM stage was the only independent predictor of shorter survival in the overall cohort (HR = 3.17, p = 0.011) and drainage group (HR = 2.80, p = 0.029). The development of complications trended toward worse survival, but this difference was not statistically significant. Higher CA 19-9 levels predicted shorter survival in univariate analysis, but were excluded from multivariate models due to missing data.

Although BD showed a trend toward longer survival, this benefit was minimal in patients with advanced-stage disease, who accounted for most early mortality post-procedure. Overall, disease stage—not drainage—was the main predictor of survival, and patients with advanced disease are unlikely to gain meaningful benefit from the BD.