Su1438 Efficacy and Safety of a Newly Developed Fully Covered Biliary Metallic Stent in Comparison With the Partially Covered WallFlex Biliary RX Stent for Unresectable Malignant Biliary Stricture Takahisa Ogawa, Kei Ito, Naotaka Fujita, Yutaka Noda, Go Kobayashi, Takashi Obana, Jun Horaguchi, Shinsuke Koshita, Yoshihide Kanno Department of Gastroenterology, Sendai City Medical Center, Sendai, Japan Background and aim: Endoscopic self-expandable metallic stent (SEMS) placement is widely accepted as a palliative therapy in patients with unresectable malignant biliary stricture. Although a covered SEMS has been reported to have a longer stent patency than an uncovered SEMS, complications such as stent migration and kinking of the bile duct can occur after deployment. A newly developed fully covered biliary metallic stent (ZEOSTENT Covered (ZEO), Zeon Medical Inc., Tokyo, Japan) which has an uneven outer surface, a low shortening ratio, and a low axial force might reduce such complications. The aim of this study was to evaluate the efficacy and safety of this new covered biliary stent in comparison with the partially covered WallFlex Biliary RX Stent (Wall) (Boston Scientific, Co., Ltd., Natic, MA, USA). Patients and methods: Between March 2010 and November 2010, endoscopic placement of a ZEO was performed in 24 patients (mean age, 77 10 yrs; 10 males, 14 females) with unresectable malignant biliary stricture. Fifteen patients had pancreatic cancer, 4 had bile duct cancer, 2 had gallbladder cancer, 2 had ampullary cancer and 1 had lymph node metastases from other cancers. Main outcome measurements were success rate of the procedure, early complications, late complications, and stent patency. Early complications were defined as those which occurred within 3 days after stent placement. Such data were compared with those of 24 patients (mean age, 75 12 yrs; 13 males, 11 females) who had undergone endoscopic placement of a Wall between April 2009 and July 2010. Results: Mean follow-up duration of the ZEO group and the Wall group were 77 days and 124 days, respectively (P 0.024). Stent placement was successful and improvement of jaundice was obtained in all patients of both groups. ZEO and Wall were transpapillarily placed in 18 and 22 patients, respectively. Transduodenal and transgastric stent placement utilizing the endosonography-guided biliary drainage route was performed in 5 and 2 patients, respectively. Early complications occurred in 1 patient in the ZEO group (pancreatitis, 1) and in 4 in the Wall group (pancreatitis, 3; cholecystitis,1) (P 0.17). Late complications occurred in 5 patients of the ZEO group (stent occlusion, 4; stent migration, 1; cholecystitis, 1) and in 6 of the Wall group (stent occlusion, 1; stent migration, 2; cholecystitis, 3; cholangitis without stent occlusion, 1) (P 1.00). In 3 cases of the ZEO group, tumor ingrowth occurred due to breakage of the cover, whereas there were no such cases in the Wall group. Mean stent patency duration of the ZEO group and the Wall group were 243 days and 382 days, respectively (P 0.20). Conclusion: The short-term efficacy and safety of ZEO were comparable with those of Wall. However, improvement of the cover of the ZEO is indispensable for prevention of tumor ingrowth.