Yu-Fei Fu1, Wen-Jie Zhou2, Yi-Bing Shi1, Wei Cao1, Chi Cao3. 1. Department of Medical Imaging, Xuzhou Central Hospital, 199 South Jiefang Road, Xuzhou, China. 2. Department of Interventional Radiology, Northern Jiangsu People's Hospital, Clinical Medical College of Yangzhou University, Yangzhou, China. 3. Department of Medical Imaging, Xuzhou Central Hospital, 199 South Jiefang Road, Xuzhou, China. xzcaochi@126.com.
Abstract
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.
RCT Entities:
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.