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The purpose of this study is to assess the relative clinical efficacy of treating malignant hilar biliary obstruction (MHBO) via percutaneous unilateral or bilateral metal stenting. Relevant articles up to December 2019 were identified within the Web of science, Pubmed, Embase, and Cochrane Library databases. Stent dysfunction served as the primary endpoint, while we assessed technical success, clinical success, early and late complication incidence, and overall survival as secondary outcomes. Pooled odds ratios (ORs) and corresponding 95% confidence intervals (CIs) were calculated for dichotomous variables. Hazard ratio (HR) with 95% CI were determined for overall survival. This meta-analysis included seven studies. Six studies were non-randomized controlled trials (RCTs) and one study was a RCT. A total of 888 MHBO patients underwent either percutaneous unilateral (n = 376) or bilateral (n = 512) metal stenting in these seven studies. We detected no significant differences in stent dysfunction rates (OR 0.97; 95% CI 0.67, 1.41, P = 0.89), technical success rates (OR 1.10; 95% CI 0.53, 2.29, P = 0.81), clinical success rates (OR 0.72; 95% CI 0.43, 1.22, P = 0.22), early complication rates (OR 0.82; 95% CI 0.34, 1.98, P = 0.66), late complication rates (OR 0.87; 95% CI 0.29, 2.63, P = 0.81), or overall survival (HR: 0.99; 95% CI 0.83, 1.17, P = 0.88) between unilateral and bilateral groups. Funnel plots demonstrated no obvious publication bias of these primary and secondary endpoints. From a clinical perspective, percutaneous unilateral and bilateral metal stenting are similarly effective for treatment of patients with MHBO. [ABSTRACT FROM AUTHOR]

Purpose: To compare the clinical outcomes between unilateral and bilateral metal stenting for patients with malignant hilar biliary obstruction (MHO). Methods: This is a single-center, open-label, prospective, randomized study. Between January 2016 and March 2018, patients with MHO who were treated by percutaneous unilateral or bilateral metal stenting were enrolled. The primary endpoint was stent dysfunction. The secondary endpoints included technical success, clinical success, adverse events, and death. The protocol is registered at ClinicalTrials.gov (identifier: NCT02649712). Results: A total of 72 patients were randomly grouped for the unilateral (n = 36) or bilateral (n = 36) stenting. The bilateral stenting was performed through the side-by-side technique. While technically, the rates of success of unilateral and bilateral stenting were 83.3% (30/36) in both the cases (P = 1.000), the clinical rates of success in unilateral and bilateral stenting were 90.0% (27/30) and 96.7% (29/30), respectively (P = 0.605). Based on the per-protocol analysis, stent dysfunction was found in 5 and 3 patients in unilateral and bilateral groups, respectively (16.7% vs. 10.0%, P = 0.704). No predictor was observed to influence stent dysfunction. The median cumulative survival in the unilateral group was 122 days and in the bilateral group was 125 days (P = 0.844). We also observed higher levels of post-operative total bilirubin and pre-operative alanine aminotransferase, and the absence of post-operative anticancer treatment as predictors of worse survival. Conclusion: When compared, the bilateral and unilateral stentings provide a similar clinical effectiveness in patients with MHO. [ABSTRACT FROM AUTHOR]