The effect of ursodeoxycholic acid following self-expandable metallic stent placement in malignant distal biliary obstruction: A propensity score-matched cohort analysis

Published:October 31, 2022DOI:
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      Background and aims

      Sludge occlusion is a primary reason for recurrent biliary obstruction (RBO) following self-expandable metallic stent (SEMS) placement. However, the efficacy of ursodeoxycholic acid (UDCA) for SEMS remains unexplored till date. This study aimed to evaluate the efficacy of UDCA following SEMS for malignant distal biliary obstruction (MDBO).


      A total of 354 patients were included, among which, 60 received UDCA. Additionally, we conducted a propensity-score matched (PSM) cohort analysis on 110 patients with SEMS placement for MDBO to reduce the selection bias. The patients were categorized into two groups (n=55 each), based on whether they received UDCA. In the UDCA group, the treatment was administered for more than a month. The primary endpoint was the time to RBO (TRBO) following SEMS. The secondary endpoint was to evaluate the SEMS occlusion rate and early adverse events (AEs).


      The cumulative SEMS occlusion rate was 41.8% and 18.2% in the groups with and without UDCA, respectively (P=0.0119). Median TRBO was significantly longer in the control group than in the UDCA group (528 vs. 154 days, P=0.0381). In the multivariate analysis, UDCA administration was identified as the independent risk factor for reducing TRBO (hazard ratio 2.28 [95% confidence interval 1.06–4.88], P=0.0348). The overall early AEs rate showed insignificant differences between the groups.


      Administering UDCA after SEMS was not efficacious for prolonging the TRBO in MDBO. Moreover, administering UDCA beyond a month might increase the risk of stent sludge occlusion.



      AEs (adverse events), ARMS (anti-reflux metallic stent), CBD (common bile duct), CI (confidence intervals), ENBD (endoscopic nasobiliary drainage), ES (endoscopic sphincterotomy), HR (hazard ratios), MDBO (malignant distal biliary obstruction), PEP (post-endoscopic retrograde cholangiopancreatography pancreatitis), PS (performance status), PSM (a propensity-score matched), RBO (recurrent biliary obstruction), SEMS (self-expandable metallic stent), TRBO (time to recurrent biliary obstruction), UDCA (ursodeoxycholic acid)
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