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

Endoscopy. 2011 Apr;43(4):317-24. doi: 10.1055/s-0030-1256294. Epub 2011 Feb 28.

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

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

Substances

  • Alloys
  • Coated Materials, Biocompatible
  • nitinol