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.
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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)
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Copyright | © Georg Thieme Verlag KG Stuttgart · New York. |
Chemical References |
- Alloys
- Coated Materials, Biocompatible
- nitinol
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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)
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