Endoscopy 2011; 43(4): 317-324
DOI: 10.1055/s-0030-1256294
Original article

© Georg Thieme Verlag KG Stuttgart · New York

A new partially covered nitinol stent for palliative treatment of malignant bile duct obstruction: a multicenter single-arm prospective study

G.  Costamagna1 , A.  Tringali1 , D.  N.  Reddy2 , J.  Devière3 , M.  Bruno4 , T.  Ponchon5 , H.  Neuhaus6 , M.  Mutignani1 , G.  V.  Rao2 , S.  Lakhtakia2 , O.  Le Moine3 , P.  Fockens4 , E.  A.  J.  Rauws4 , V.  Lepilliez5 , B.  Schumacher6 , A.  Seelhoff6 , D.  Carr-Locke7
  • 1Università Cattolica del Sacro Cuore, Rome, Italy
  • 2Asian Institute of Gastroenterology, Hyderabad, India
  • 3Hospital Erasme, Université Libre de Bruxelles, Brussels, Belgium
  • 4Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands
  • 5Hospital Edouard Herriot, Lyon, France
  • 6Medizinische Klinik, EVK Düsseldorf, Düsseldorf, Germany
  • 7Beth Israel Medical Center, New York, USA
Further Information

Publication History

submitted 18 April 2010

accepted after revision 11 October 2010

Publication Date:
28 February 2011 (online)

Background and study aims: Covered self-expanding metal stents (SEMSs) have proven effective for managing malignant bile duct strictures and may reduce risk of tumor ingrowth. A new nitinol partially covered biliary SEMS was prospectively evaluated.

Patients and methods: 70 patients with inoperable extrahepatic biliary obstructions were enrolled in a prospective multicenter trial, and followed up to 6 months or death, whichever came first. Primary endpoint was adequate palliation defined as absence of recurrent biliary obstruction from partly covered SEMS placement to end of follow-up.

Results: Mean age of the patients was 69 years and 52 % were men. Pancreatic carcinoma was present in 68 %. One stent was placed in 67 patients, two patients received two, and in one patient a guide wire could not traverse the stricture. In 55 % of patients the SEMS was inserted de novo and in 45 % for exchange with a plastic stent. Technical success was 97 %. At 6 months, 62 % of patients were free of obstructive symptoms; compared with baseline the mean number of symptoms per patient was significantly reduced (3.1 at baseline, 0.6 at 6 months; P < 0.0001) and total bilirubin levels dropped by 73 %. There were four cases of recurrent biliary obstruction, due to stent migration (2), tumor overgrowth (1), and sludge formation (1). Device-related complications included cholecystitis (3), right upper quadrant pain (1), and moderate pancreatitis (1). No tumor ingrowth was reported.

Conclusions: This new partially covered nitinol SEMS is easily inserted, and safe and effective in the palliation of biliary obstruction secondary to malignant bile duct strictures.

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G. CostamagnaMD 

Digestive Endoscopy Unit, Catholic University

Largo A. Gemelli 8
00168 Rome
Italy

Fax: +39-06-30156581

Email: gcostamagna@rm.unicatt.it