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 gamma GT 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.