The WallFlex® Fully Covered Self Expandable Metal Stent (CSEMS) is Effective and Safe to Treat Distal Malignant Biliary Strictures, Irrespective of Surgical Resectability Status

Abstract

Purpose: Biliary obstruction due to pancreatic cancer is usually treated by placement of plastic stents if a curative resection is contemplated, leaving self expandable metal stent (SEMS) for patients with unresectable disease. We report a retrospective analysis of patients with malignant biliary obstruction in whom a fully silicon-covered self expandable metal stent (CSEMS) [WallFlex®, Microvasive Endoscopy] were placed for management of their obstruction. Methods: Between March 2009 and March 2010, all patients with obstructive jaundice secondary to pancreatic cancer underwent placement of a CSEMS (10-mm diameter) regardless of resectability. A CSEMS Wallstent (40, 60 or 80 mm in length) was placed across the malignant stricture and below the cystic duct in patients with a gallbladder. These patients were then staged for their cancer by CT, MRI and/or EUS-FNA. Patient found to have resectable cancer were offered a pancreaticoduodenectomy. Results: We identified 46 patients (28 male, mean age= 68±15 years old) with pancreatic cancer who received a WallFlex® CSEMS. 27 patients were deemed resectable and underwent surgery. Pancreaticoduodenectomy was performed in 21/27 patients (78%). Patients deemed unresectable underwent biliary bypass. The CSEMS was easily removed at the time of surgical resection without any complications. The 16 unresected patients with covered SEMS were followed for a mean of 4.6 months (range: 1-9). The patency rate for stents was 100%. Procedural complications included post-ERCP pancreatitis (n=1) and stent migrations (n=2). There were no cases of stent occlusion or cholecystitis during the follow-up. The 2 patients who presented with stent migration underwent revision, with removal and replacement of the SEMS during a single procedure. Conclusion: Placement of the newly available WallFlex® fully covered SEMS can be used effectively and safely to treat biliary obstruction from pancreatic carcinoma. The CSEMS can be easily removed in patients undergoing surgical resection or those who require revision of their SEMS endoscopically. We recommend that the CSEMS be used as an initial intervention to relieve malignant biliary obstruction, even in patients whose the surgical resectability status is uncertain.