Clinical outcomes of nitinol and stainless steel uncovered metal stents for malignant biliary strictures: is there a difference?

Gastrointest Endosc. 2010 Dec;72(6):1195-200. doi: 10.1016/j.gie.2010.08.035.

Abstract

Background: Self-expandable metal stents (SEMSs) made from nitinol (N) were developed as a potentially more effective alternative to conventional stainless steel (SS) stents.

Objective: To compare clinical outcomes of N versus SS stents in the management of malignant biliary strictures.

Design: Retrospective study.

Setting: Tertiary-care cancer center.

Patients: All patients with first-time N (Flexxus) and SS (Wallstent) uncovered biliary SEMSs placed between January 2006 and October 2007.

Interventions: SEMS placement.

Results: A total of 81 N and 96 SS stents were placed. The most common cancer diagnosis was pancreatic (80.2% N; 62.5% SS; P = .06). The most frequent site of stricture was the common bile duct (85.2% N; 86.5% SS; P = .31). Biliary decompression was achieved in 93.8% of the N group and 86.4% of the SS group (P = .22). Immediate stent manipulation was required in 4 patients in each group. Subsequent intervention for poor drainage was performed in 17 N (21%) and 26 SS (27%) stents at mean times of 142.1 days (range, 5-541 days; median, 77 days) and 148.1 days (range, 14-375; median, 158.5), respectively (P = .17). The occlusion rate between N and SS stents was not significant (P = .42). The overall durations of stent patency in the N and SS group were similar (median 129 and 137 days, respectively; P = .61), including the subgroup analysis performed on patients with pancreatic cancer (P = .60) and common duct strictures (P = .77). Complication rates were low in both groups (early: 3.7% N, 6.3% SS; late: 2.5% N, 3.1% SS). Ninety percent underwent chemotherapy and 38% radiation therapy in each group.

Limitations: Retrospective design.

Conclusion: Similar outcomes were achieved with N and SS stents regarding efficacy, duration of stent patency, occlusion rates, and complications. Our results are most applicable to patients with common duct strictures and pancreatic cancer.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Alloys*
  • Ampulla of Vater*
  • Cholangiocarcinoma / therapy*
  • Cholestasis, Extrahepatic / therapy*
  • Common Bile Duct Neoplasms / secondary
  • Common Bile Duct Neoplasms / therapy*
  • Equipment Failure Analysis
  • Female
  • Hepatic Duct, Common*
  • Humans
  • Liver Function Tests
  • Liver Neoplasms / secondary*
  • Liver Neoplasms / therapy
  • Male
  • Middle Aged
  • Pancreatic Neoplasms / secondary
  • Pancreatic Neoplasms / therapy*
  • Prosthesis Design
  • Recurrence
  • Retreatment
  • Retrospective Studies
  • Stainless Steel*
  • Stents*

Substances

  • Alloys
  • Stainless Steel
  • nitinol