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

Abstract

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.

• Authors: G Costamagna, A Tringali, D N Reddy, J Devière, M Bruno, T Ponchon, H Neuhaus, M Mutignani, G V Rao, S Lakhtakia, O Le Moine, P Fockens, E A Rauws, V Lepilliez, B Schumacher, A Seelhoff, D Carr-Locke
• Journal: Endoscopy (Endoscopy) Vol. 43 Issue 4 Pg. 317-24 (Apr 2011) ISSN: 1438-8812 [Electronic] Germany
• PMID: 21360423 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © Georg Thieme Verlag KG Stuttgart · New York.

Chemical References

• Alloys
• Coated Materials, Biocompatible
• nitinol

Topics

• Adult
• Aged
• Aged, 80 and over
• Alloys
• Bile Duct Neoplasms (complications, secondary)
• Cholestasis, Extrahepatic (etiology, surgery)
• Coated Materials, Biocompatible
• Common Bile Duct Diseases (etiology, surgery)
• Female
• Humans
• Male
• Middle Aged
• Palliative Care
• Stents (adverse effects)