Background: Biliary drainage is recommended for unresectable malignant Extrahepatic Biliary Obstruction (EHBO) to palliate jaundice, pruritus, and cholangitis, yet real-world data from India on uncovered Self-Expanding Metal Stents (SEMS) remain limited.
Methods: This single-center retrospective analysis of prospectively collected data from GB Pant Hospital, New Delhi, evaluated stent patency and survival after uncovered biliary SEMS insertion in biopsy-proven unresectable malignant EHBO (Bismuth types 1-3 and distal obstruction) between September 1st, 2023, and December 31st, 2024, with biweekly follow-up until March 13th, 2025, or death. The primary outcome was stent patency at 3 months; secondary outcomes included clinical success at 2 weeks, 6 month survival, and adverse events.
Results: Forty-nine patients were included, most commonly with gallbladder carcinoma (67%); 95.8% had ECOG performance status ≤ 2. Technical success was 100% and clinical success 86%. ERCP-related adverse events occurred in five patients (Three perforation: managed as two conservative, one surgical; one post-sphincterotomy bleed; one aspiration pneumonia), with two procedure-related deaths (aspiration pneumonia and surgically managed perforation). Only 24% initiated chemotherapy post stenting. Median survival was 89 days, with 20.7% alive at 6 months and most deaths attributable to disease progression.
Conclusion: Uncovered SEMS showed high technical success and acceptable short-term clinical efficacy, but a very high 6-month mortality rate, due to limited access to chemotherapy and aggressive gallbladder cancer, which may lessen the practical benefit of SEMS compared to plastic stents in settings with limited palliative oncological therapy.
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