Self-expandable metal stents improve patency and survival in malignant hilar biliary obstruction
This systematic review and meta-analysis of individual patient data pooled results from 5 randomized controlled trials involving 322 patients with unresectable malignant hilar biliary obstruction requiring palliative endoscopic drainage. The analysis compared self-expandable metal stents (SEMSs) to plastic stents (PSs) for the primary outcomes of stent patency and overall survival, with secondary outcomes including reintervention, technical success, clinical success, and adverse events.
For stent patency, SEMSs showed a significant improvement compared to PSs (hazard ratio [HR], 0.49; 95% CI, 0.35-0.68). Overall survival was also significantly better with SEMSs (HR, 0.60; 95% CI, 0.47-0.78). The need for reintervention was lower with SEMSs (relative risk [RR], 0.76; 95% CI, 0.59-0.97). No significant differences were found between groups for technical success or clinical success.
Safety analysis showed no significant differences in adverse event rates, including pancreatitis, cholecystitis, and cholangitis. The absolute numbers for these events, serious adverse events, discontinuations, and tolerability were not reported. The study did not report the specific follow-up duration for patients.
Key limitations include the meta-analysis being based on a limited number of trials (5 RCTs) with 322 total patients. Absolute event rates and the specific follow-up duration are not reported, and individual trial characteristics are not detailed in this summary. The findings reinforce previous guideline recommendations for preferential use of SEMSs in this setting, but clinicians should consider the evidence base size when applying these results.
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