AIM: To investigate the clinical efficiency of percutaneous trans-hepatic bilateral biliary metallic stenting for the management of Bismuth Ⅳ malignant obstructive disease. METHODS: Our hospital’s database was searched for all patients suffering from the inoperable malignant biliary obstruction Bismuth Ⅳ, and treated with percutaneous bilateral trans-hepatic placement of selfexpandable nitinol stents. The indication for percutaneous stenting was an inoperable, malignant, symptomatic, biliary obstruction. An un-correctable coagulation disorder was the only absolute contra-indication for treatment. Bismuth grading was performed using magnetic resonance cholangiopancreatography. Computed tomography evaluation of the lesion and the dilatation status of the biliary tree was always performed prior to the procedure. All procedures were performed under conscious sedation. A single trans-hepatic track technique was preferred (T-configuration stenting) and a second, contra-lateral trans-hepatic track (Y-configuration stenting) was used only in cases of inability to access the contra-lateral lobe using a single track technique. The study’s primary endpoints were clinical success, defined as a decrease in bilirubin levels within 10 d and patient survival rates. Secondary endpoints included peri-procedural complications, primary and secondary patency rates. RESULTS: A total of 35 patients (18 female, 51.4%) with a mean age 69 ± 13 years (range 33-88) were included in the study. The procedures were performed between March 2000 and June 2008 and mean time follow-up was 13.5 ± 22.0 mo (range 0-96). The underlying malignant disease was cholangiocarcinoma (n = 10), hepatocellular carcinoma (n = 9), pancreatic carcinoma (n = 5), gastric cancer (n = 2), bile duct tumor (n = 2), colorectal cancer (n = 2), gallbladder carcinoma (n = 2), lung cancer (n = 1), breast cancer (n = 1) or non-Hodgkin lymphoma (n = 1). In all cases, various self-expandable bare metal stents with diameters ranging from 7 to 10 mm were used. Stents were placed in Y-configuration in 24/35 cases (68.6%) using two stents in 12/24 patients and three stents in 12/24 cases (50%). A T-configuration stent placement was performed in 11/35 patients (31.4%), using two stents in 4/11 cases (36.4%) and three stents in 7/11 cases (63.6%). Follow-up was available in all patients (35/35). Patient survival ranged from 0 to 1763 d and the mean survival time was 168 d. Clinical success rate was 77.1% (27/35 cases), and peri-procedural mortality rate was 5.7% (2/35 patients). Biliary reobstruction due to stent occlusion occurred in 25.7% of the cases (9/35 patients), while in 7/11 (63.6%) one additional percutaneous re-intervention due to stent occlusion resulting in clinical relapse of symptomatology was successfully performed. In the remaining 4/11 patients (36.4%) more than 1 additional reintervention was performed. The median decrease of total serum bilirubin was 60.5% and occurred in 81.8% of the cases (27/33 patients). The median primary and secondary patency was 105 (range 0-719) and 181 d (range 5-1763), respectively. According to the KaplanMeyer survival analysis, the estimated survival rate was 73.5%, 47.1% and 26.1% at 1, 6 and 12 mo respectively, while the 8-year survival rate was 4.9%. Major and minor complication rates were 5.7% (2/35 patients) and 17.1% (6/35 patients), respectively. CONCLUSION: Percutaneous bilateral biliary stenting is a safe and clinically effective palliative approach in patients suffering from Bismuth Ⅳ malignant obstruction. A investigate: investigate the clinical efficiency of percutaneous trans-hepatic bilateral biliary metallic stenting for the management of Bismuth IV malignant obstructive disease. METHODS: Our hospital’s database was searched for all patients suffering from the inoperable malignant biliary obstruction Bismuth IV, and treated with percutaneous bilateral trans-hepatic placement of selfexpandable nitinol stents. The indication for percutaneous stenting was an inoperable, malignant, symptomatic, biliary obstruction. An un-correctable coagulation disorder was the only absolute contra-indication for treatment. Bismuth grading was performed using magnetic resonance cholangiopancreatography . Computed tomography evaluation of the lesion and the dilatation status of the biliary tree was always performed prior to the procedure. All procedures were performed under conscious sedation. A single trans-hepatic track technique was preferred (T-configuration stenting) and a second, contra-lateral trans-hepa tic track (Y-configuration stenting) was used only in cases of inability to access the contra-lateral lobe using a single track technique. The study’s primary endpoints were clinical success, defined as a decrease in bilirubin levels within 10 d and patient survival rates RESULTS: A total of 35 patients (18 female, 51.4%) with a mean age of 69 ± 13 years (range 33-88) were included in the study. The procedures were performed between March 2000 and June 2008 and mean time follow-up was 13.5 ± 22.0 mo (range 0-96). The underlying malignant disease was cholangiocarcinoma (n = 10), hepatocellular carcinoma (n = 9), pancreatic carcinoma n = 5, gastric cancer n = 2, bile duct tumor n = 2, colorectal cancer n = 2, gallbladder carcinoma n = 1, breast cancer n = 1) or non-Hodgkin lymphoma (n = 1). In all cases, various self-expandable bare metal stents with diameters ranging from 7 to 10 mm were used. Stents were placed in Y-configuration in 24/35 cases (68.6%) using two stents in 12/24 patients and three stents in 12/24 cases (50%). A T-configuration stent placement was performed in 11/35 patients (31.4%), using two stents in 4/11 cases (36.4%) and three stents in 7/11 cases (63.6%). Follow-up was available in all patients (35 / 35). Patient survival ranged from 0 to 1763 d and the mean survival time was 168 d. Clinical success rate was 77.1% (27/35 cases), and peri-procedural mortality rate was 5.7% (2/35 patients). reobstruction due to stent occlusion occurred in 25.7% of the cases (9/35 patients), while in 7/11 (63.6%) one additional percutaneous re-intervention due to stent occlusion resulting in clinical relapse of symptomatology was successfully performed. In the The remaining 4/11 patients (36.4%) more than 1 additional reintervention was performed. The median decrease of total serum bilirubin was 60.5% and occurred in 81.8% of the cases (27/33 The median primary and secondary patency was 105 (range 0-719) and 181 d (range 5-1763), respectively. According to the Kaplan Meyer survival analysis, the estimated survival rate was 73.5%, 47.1% and 26.1% at While the 8-year survival rate was 4.9%. Major and minor complication rates were 5.7% (2/35 patients) and 17.1% (6/35 patients), respectively. CONCLUSION: Percutaneous bilateral biliary stenting is a safe and clinically effective palliative approach in patients suffering from Bismuth Ⅳ malignant obstruction.