To compare the effectiveness between C-SEMS placed above and across Roxadustat SO in patients with malignant biliary obstruction. From February 2010 to September 2012, this study was conducted in 6 centers from Korea and 6 centers from Japan. Total of 84 cases with unresectable malignant biliary obstruction were randomized into either Group A

(above SO without biliary sphincterotomy, n=40) or B (across SO after biliary sphincterotomy, n=44). Biliary obstruction was defined as bile duct obstruction located at least 2.0 cm distal to bifurcation and 0.5 cm proximal to the ampulla. Niti-S ComVi fully covered biliary stent ® (Taewoong Medical, Seoul, Korea) was used. Data of 37 cases from Group A and 38 from Group B were available for final analysis. Between Groups A and B, there was no significant difference regarding gender, age (70.5±12.9 vs. 73.9±12.2 yrs, p=0.238), duration of follow-up (177 [IQR 110-287] vs. 192 [IQR 73-316] days. p=0.801), diagnosis, biochemical profiles, level of biliary obstruction, tumor morphology, length of obstruction, and Karnofsky score (81±10 vs. 77±12, p=0.116). Mean C-SEMS patency period were 160.6 ± 102.8 days for Group A and BGB324 cost 191.2 ± 118.3 days for Group B, respectively (p= 0.284). Occlusion rate were 43.2% and 28.9% for Groups A and B (p=0.197). Mean survival periods were 221.8±171.1 days for

Group A and 284±174.5 days for Group B (p=0.414). Cholangitis without stent

occlusion occurred 2 cases in group A and 2 cases in group B (p=0.978). Between two groups, there was no significant difference regarding stent-related complications such as pancreatitis (0 vs. 1), cholecystitis (1 vs. 2), external migration (0 vs. 3, p=0.199) and bleeding (none). Occlusion rates in patients of pancreatic cancer were 55.0% in Group A and 21.1% in Group B (p=0.029), respectively. C-SEMS placement above the SO did not prolong stent patency and did not reduce development of cholangitis without occlusion. Sinomenine C-SEMS placement across the SO may result in more external migration. In cases with pancreatic cancer, stent occlusion occurred more often in C-SEM placement above the SO. “
“Self expandable metallic stent (SEMS) has been widely used for palliation of distal malignant obstructive jaundice. In a randomized controlled trial, we compare a steel alloy SEMS (sSEMS), Wallstent® with a nitinol SEMS (nSEMS), Wallflex® (Boston Scientific). To evaluate stent patency, survival and complications after endoscopically placed nSEMS vs sSEMS in patients with distal non-resectable malignant bile duct obstruction. Patients were randomized to receive a partially covered Wallflex® or Wallstent®. To demonstrate a difference of 15% between two stents, alfa 5% and beta 92%, 400 patientes were needed.