Prospective evaluation of the partially covered nitinol "ComVi" stent for malignant non hilar biliary obstruction.

Abstract

BACKGROUND:

Biliary partially covered self-expandable metal stents (PC-SEMS) offer prolonged relief of symptoms of biliary obstruction but may induce complications including pancreatitis, cholecystitis and migration.

AIMS:

To assess efficacy and safety of the ComVi partially covered self-expandable metal stents as primary palliative treatment of distal malignant biliary obstruction.

METHODS:

Seventy patients (mean age 69.2 years) with distal malignant biliary strictures were prospectively included and underwent endoscopic retrograde cholangio-pancreatography and partially covered self-expandable metal stents placement. Follow-up was done for 12 months. self-expandable metal stents patency, survival and complication-rate after partially covered self-expandable metal stents placement were evaluated.

RESULTS:

Overall median survival time was 190 days (30-856). Forty-four patients (62.8%) died after median 175.5 days (30-614) without signs of stent dysfunction; 37 patients (52.8%) were alive after 6 months without signs of self-expandable metal stents occlusion. Survival rapidly dropped between 8 and 12 months after treatment. Survival was not influenced by sex (P = 0.1) or type of neoplasia (P = 0.178). Median survival was longer (254 days [44-836]) in patients who underwent chemotherapy (P < 0.0001). Partially covered self-expandable metal stents occlusion had 24 (35.7%) patients 154 days (35-485) after treatment. Median survival after re-treatment was 66 days (13-597). Cholecystitis occurred in one patient (1.7%).

CONCLUSIONS:

The ComVi partially covered self-expandable metal stents is effective for palliation of biliary obstruction secondary to distal malignant biliary strictures. Self-expandable metal stents patency during follow-up is satisfactory without significant complications.

• Authors: Vincenzo Perri, Ivo Boškoski, Andrea Tringali, Pietro Familiari, Michele Marchese, Dong Ki Lee, Sung Il Jang, Jimin Han, Ho Gak Kim, Massimiliano Mutignani, Graziano Onder, Guido Costamagna
• Journal: Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver (Dig Liver Dis) Vol. 45 Issue 4 Pg. 305-9 (Apr 2013) ISSN: 1878-3562 [Electronic] Netherlands
• PMID: 23218991 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
• Copyright: Copyright © 2012 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Chemical References

• Alloys
• nitinol
• Bilirubin

Topics

• Adult
• Aged
• Aged, 80 and over
• Alloys
• Bilirubin (blood)
• Cholangiopancreatography, Endoscopic Retrograde
• Cholestasis (blood, etiology, surgery)
• Female
• Follow-Up Studies
• Humans
• Logistic Models
• Male
• Middle Aged
• Multivariate Analysis
• Neoplasms (complications)
• Palliative Care
• Proportional Hazards Models
• Stents (adverse effects)