Use of fully covered self-expanding metal stents for the management of benign biliary conditions

Abstract

Background and aim: biliary self-expanding metal stents (SEMS) have the advantage of being inserted undeployed with very small sizes and provide, when fully opened, large diameters for biliary drainage. However, their use in benign conditions has been very limited, mainly because of difficulty in their extraction. We present our initial experience with a fully covered SEMS (Wallflex) for the management of benign problems of the bile duct. Patients and methods: in a prospective study, stents of 8 mm in diameter and 4, 6 or 8 cm long were inserted by means of ERCP. These SEMS were chosen when according to medical judgement it was thought that diameters greater than 10 French (3.3 mm) were needed for proper biliary drainage. Stents were extracted also endoscopically, several months later when deemed clinically appropriate. Results: twenty biliary SEMS were inserted. Reasons for insertion were: large intrahepatic biliary fistula after hydatid cyst surgery (1), perforation of the papillary area following endoscopic sphincterotomy (2), coaxial insertion to achieve patency in obstructed uncovered stents inserted in benign conditions (3), benign strictures (7), multiple and large common bile duct stones that could not be extracted because of tapering and stricturing of the distal common bile duct (7). In all cases, successful biliary drainage was achieved and there were no complications from insertion. Stents were easily extracted after a mean time of 132 days (36-270) in place. Complete resolution of biliary problems was obtained in 14 patients (70%). Conclusions: in our initial experience, the fully covered Wallflex biliary stent was removed without any complication after being in place in the common bile duct for a mean time of over four months. Therefore, it could be used in the management of benign biliary conditions.

Short-term stenting using fully covered self-expandable metal stents for treatment of refractory biliary leaks, postsphincterotomy bleeding, and perforations

“…However, the 1982 [2] development of duodenoscopes with 4.2-mm working channels allowed the use of large-bore (10-11.5-French) plastic stents. Ten-French stents are now the standard caliber, because use of 11.5-Fr plastic stents is more technically challenging and does not increase stent patency [3]. Plastic stents are routinely used to treat benign biliary conditions (BBCs) such as biliary leaks [4][5][6], strictures [7], postsphincterotomy bleeding (post-ES bleeding) [8], and perforations [9,10].…”

“…Because uncovered SEMSs soon become embedded into body tissues, their removal is difficult, if not impossible, which limits their use in BBCs [3,18,19]. Covered SEMS were designed to prevent tumor ingrowth and reactive tissue hyperplasia through the stent mesh.…”

“…Covered SEMS were designed to prevent tumor ingrowth and reactive tissue hyperplasia through the stent mesh. This cover prevented the metal from embedding into the biliary tract, allowing for removability [3,[19][20][21][22]. The first covered stents were coated in the middle and had both ends uncovered.…”

“…The full coverage of the stent decreased the incidence of complications and made stent removal safer and easier [3,[24][25][26]. Although not approved by the Food and Drug Administration, temporary FCSEMS placement is an excellent option in a subgroup of patients with BBCs that do not respond to plastic stent placement or to the usual endoscopic therapies [3,[24][25][26].…”

“…The full coverage of the stent decreased the incidence of complications and made stent removal safer and easier [3,[24][25][26]. Although not approved by the Food and Drug Administration, temporary FCSEMS placement is an excellent option in a subgroup of patients with BBCs that do not respond to plastic stent placement or to the usual endoscopic therapies [3,[24][25][26]. However, recent papers using FCSEMSs in BBCs [3,[24][25][26] reported complications, including duodenal migration [24,26], bile duct ulcerations [25], de novo choledocholithiasis [25], strictures [3,25], and even periampullary adenoma [25].…”