BACKGROUND: Recently, placement of fully covered self-expandable metal stents (FCSEMSs) has been proposed as an alternative treatment for the management of benign biliary strictures. However, the major limitations of FCSEMSs are frequent migration and removal complications. OBJECTIVE: We conducted this study to compare the antimigration effects, complication rates, and short-term efficacy of 2 FCSEMSs with either an anchoring flap (AF) or a flared end (FE) at the proximal end of the stent. DESIGN: A multicenter, prospective comparative pilot study. SETTING: Two tertiary referral centers. PATIENTS: A total of 43 patients with benign biliary stricture who were candidates for placement of FCSEMSs were assigned to the AF (n = 22) or the FE group (n = 21). INTERVENTIONS: Predefined duration of placement and removal of FCSEMSs. RESULTS: After a median period of placement of 6 months (interquartile range 4-6), no patients in the AF group and 33% of patients (7 of 21, 1 in proximal and 6 in distal) in the FE group had stent migration (P = .004). The removal rate of the FCSEMSs was 100% in both groups (per protocol, n = 22 in the AF group and n = 17 in the FE group). Immediate improvement of biliary stricture was 91% (20/22, per protocol) in the AF group and 88% (15/17, per protocol) in the FE group. All stents were removed without difficulty. LIMITATIONS: Short-term follow-up after the removal of FCSEMSs. CONCLUSIONS: With regard to the antimigration effect of FCSEMSs for benign biliary stricture, the AF design may be superior to the FE. For up to 6 months, both FCSEMSs can be endoscopically removed without complications. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00945516.).
BACKGROUND: Recently, placement of fully covered self-expandable metal stents (FCSEMSs) has been proposed as an alternative treatment for the management of benign biliary strictures. However, the major limitations of FCSEMSs are frequent migration and removal complications. OBJECTIVE: We conducted this study to compare the antimigration effects, complication rates, and short-term efficacy of 2 FCSEMSs with either an anchoring flap (AF) or a flared end (FE) at the proximal end of the stent. DESIGN: A multicenter, prospective comparative pilot study. SETTING: Two tertiary referral centers. PATIENTS: A total of 43 patients with benign biliary stricture who were candidates for placement of FCSEMSs were assigned to the AF (n = 22) or the FE group (n = 21). INTERVENTIONS: Predefined duration of placement and removal of FCSEMSs. RESULTS: After a median period of placement of 6 months (interquartile range 4-6), no patients in the AF group and 33% of patients (7 of 21, 1 in proximal and 6 in distal) in the FE group had stent migration (P = .004). The removal rate of the FCSEMSs was 100% in both groups (per protocol, n = 22 in the AF group and n = 17 in the FE group). Immediate improvement of biliary stricture was 91% (20/22, per protocol) in the AF group and 88% (15/17, per protocol) in the FE group. All stents were removed without difficulty. LIMITATIONS: Short-term follow-up after the removal of FCSEMSs. CONCLUSIONS: With regard to the antimigration effect of FCSEMSs for benign biliary stricture, the AF design may be superior to the FE. For up to 6 months, both FCSEMSs can be endoscopically removed without complications. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00945516.).
Authors: Shayan Irani; Todd H Baron; Ali Akbar; Otto S Lin; Michael Gluck; Ian Gan; Andrew S Ross; Bret T Petersen; Mark Topazian; Richard A Kozarek Journal: Dig Dis Sci Date: 2013-09-24 Impact factor: 3.199
Authors: Payal Saxena; David L Diehl; Vivek Kumbhari; Frederick Shieh; Jonathan M Buscaglia; Wilson Sze; Sumit Kapoor; Srinadh Komanduri; John Nasr; Eun Ji Shin; Vikesh Singh; Anne Marie Lennon; Anthony N Kalloo; Mouen A Khashab Journal: Dig Dis Sci Date: 2015-04-08 Impact factor: 3.199
Authors: Arthur Schmidt; Tilman Pickartz; Markus M Lerch; Fabrizio Fanelli; Fausto Fiocca; Pierleone Lucatelli; Fabrizio Cereatti; Albrecht Hoffmeister; Werner van Steenbergen; Matthias Kraft; Benjamin Meier; Karel Caca Journal: United European Gastroenterol J Date: 2016-09-07 Impact factor: 4.623