| Abstract: | Background: Occlusion due to tumor ingrowth is a major drawback in self‐expandable metallic stents. Covering the stent is a probable solution to prevent tumor ingrowth. A manufactured covered self‐expandable metallic stent, Covered Wallstent, has become commercially available. We evaluated the Covered Wallstent in a prospective uncontrolled multicenter setting. Methods: Between October 2001 and October 2003, 97 patients with common bile duct strictures deemed unfit for surgical resection underwent placement of a single Covered Wallstent, and were followed prospectively until April 2004. Results: Placement of the stent was successful in all the patients attempted. As a procedure‐related complication, acute pancreatitis developed in four patients, in one of whom obstruction of the pancreatic duct orifice with the stent body seemed to be a major cause. The 30‐day mortality was 9.3% (nine patients). Stent occlusion occurred in 22 patients as a late (greater than 30 days) complication, due to either tumor overgrowth (14 patients) or encrustation (eight patients). Distal migration of the stent was demonstrated in two other patients. No stent occlusions due to tumor ingrowth were observed. Patency rates of the stent for 3‐, 6‐, and 12‐month periods were, respectively, 90.7, 82.5, and 45.9%. Conclusions: The present results in a large series suggest that placement of the Covered Wallstent is feasible and effective in the palliation of patients with malignant common bile duct strictures. The Covered Wallstent seems to be reliable in eliminating tumor ingrowth. The role of stent covering in promoting stent function should be examined in a prospective comparative study between covered‐ and uncovered Wallstents. |
