Percutaneous insertion of a novel dedicated metal stent to treat malignant hilar biliary obstruction

BACKGROUND: Percutaneous bilateral biliary stenting is an established method for the management of unresectable malignant hilar biliary obstruction. AIM: To evaluate the efficacy and safety of a novel uncovered biliary stent, specifically designed for hilar reconstruction. METHODS: This, single-center, retrospective study included 18 patients (mean age 71 ± 11 years; 61.1% male) undergoing percutaneous transhepatic Moving cell stent (MCS) placement for hilar reconstruction using the stent-in-stent technique for malignant biliary strictures, between November 2020 and July 2021. The Patients were diagnosed with cholangiocarcinoma (12/18; 66.6%), gallbladder cancer (5/18; 27.7%), and colorectal liver metastasis (1/18; 5.5%). Primary endpoints were technical (appropriate stent placement) and clinical (relief from jaundice) success. Secondary endpoints included stent patency, overall survival, complication rates and stent-related complications. RESULTS: The technical and clinical success rates were 100% (18/18 cases). According to Kaplan-Meier analysis, the estimated overall patient survival was 80.5% and 60.4% at 6 and 12 mo respectively, while stent patency was 90.9% and 68.2% at 6 mo and 12 mo respectively. The mean stent patency was 172.53 ± 56.20 d and median stent patency was 165 d (range 83-315). Laboratory tests for cholestasis significantly improved after procedure: mean total bilirubin decreased from 15.2 ± 6.0 mg/dL to 1.3 ± 0.4 mg/dL (P < 0.001); mean γGT decreased from 1389 ± 832 U/L to 114.6 ± 53.5 U/L (P < 0.001). One periprocedural complication was reported. Stent-related complications were observed in 5 patients (27.7%), including 1 occlusion (5.5%) and 1 stent migration (5.5 %). CONCLUSION: Percutaneous hilar bifurcation biliary stenting with the MCS resulted in excellent clinical and technical success rates, with acceptable complication rates. Further studies are needed to confirm these initial positive results.