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

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.