Digestive and Liver Disease 45 (2013) 305–309 Contents lists available at SciVerse ScienceDirect Digestive and Liver Disease j our nal ho me page: www.elsevier.com/locate/dld Digestive Endoscopy Prospective evaluation of the partially covered nitinol “ComVi” stent for malignant non hilar biliary obstruction  Vincenzo Perri a , Ivo Boˇ skoski a , Andrea Tringali a , Pietro Familiari a , Michele Marchese a , Dong Ki Lee b , Sung Il Jang b , Jimin Han c , Ho Gak Kim c , Massimiliano Mutignani a , Graziano Onder a , Guido Costamagna a,∗ a Digestive Endoscopy Unit, Gemelli University Hospital, Università Cattolica del Sacro Cuore, Rome, Italy b Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University, South Korea c Department of Internal Medicine, Catholic University of Daegu School of Medicine, Taegu, South Korea a r t i c l e i n f o Article history: Received 29 July 2012 Accepted 1 November 2012 Available online 6 December 2012 Keywords: Biliary neoplasms Biliary strictures ERCP Pancreatic cancer Self-expandable metal stents a b s t r a c t Background: Biliary partially covered self-expandable metal stents (PC-SEMS) offer prolonged relief of symptoms of biliary obstruction but may induce complications including pancreatitis, cholecystitis and migration. Aims: To assess efficacy and safety of the ComVi partially covered self-expandable metal stents as primary palliative treatment of distal malignant biliary obstruction. Methods: Seventy patients (mean age 69.2 years) with distal malignant biliary strictures were prospec- tively included and underwent endoscopic retrograde cholangio-pancreatography and partially covered self-expandable metal stents placement. Follow-up was done for 12 months. self-expandable metal stents patency, survival and complication-rate after partially covered self-expandable metal stents placement were evaluated. Results: Overall median survival time was 190 days (30–856). Forty-four patients (62.8%) died after median 175.5 days (30–614) without signs of stent dysfunction; 37 patients (52.8%) were alive after 6 months without signs of self-expandable metal stents occlusion. Survival rapidly dropped between 8 and 12 months after treatment. Survival was not influenced by sex (P = 0.1) or type of neoplasia (P = 0.178). Median survival was longer (254 days [44–836]) in patients who underwent chemotherapy (P < 0.0001). Partially covered self-expandable metal stents occlusion had 24 (35.7%) patients 154 days (35–485) after treatment. Median survival after re-treatment was 66 days (13–597). Cholecystitis occurred in one patient (1.7%). Conclusions: The ComVi partially covered self-expandable metal stents is effective for palliation of biliary obstruction secondary to distal malignant biliary strictures. Self-expandable metal stents patency during follow-up is satisfactory without significant complications. © 2012 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved. 1. Introduction Endoscopic stenting for unresectable malignancies of the com- mon bile duct (CBD) is considered the gold standard procedure for palliation of biliary obstruction.  No sources of support in the form of grants, equipment, drugs, or all of the above have been received. Taewoong Medical Inc., Seoul, Korea offered the Niti-S stent, ComVi type for the completion of the study without any charge. ∗ Corresponding author at: Catholic University, Largo A. Gemelli 8, 00168 Rome, Italy. Tel.: +39 06 30156580; fax: +39 06 30156581. E-mail addresses: pietrofamiliari@tiscali.it (P. Familiari), gcostamagna@rm.unicatt.it (G. Costamagna). The endoscopic approach to malignant non hilar strictures has low complications rate, is widely available and reproducible even in low volume centres. Self-expandable metal stents (SEMS) are more expensive than plastic stents but have a longer patency [1]. Effective endoscopic biliary drainage may allow use or prosecu- tion of palliative radiochemotherapy. Tissue ingrowth from hyperplasia or neoplastic growth through the meshes of uncovered SEMS is one of the main causes of stent occlusion [2,3]. Covered SEMS were developed to overcome this problem [4–6]. Covered SEMS might increase stent patency related to ingrowth, but could favour complications related to stent cov- ering, such as cholecystitis, migration and pancreatitis [4,5,7,8]. Migration of SEMS can be reduced by the partially covered design. High linear tension (axial force), is the tendency of some stents to straighten. This force can lead to impaction of the proximal end of 1590-8658/$36.00 © 2012 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.dld.2012.11.001