Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective, comparative pilot study (with videos) - 12/08/11
Reprint requests: Do Hyun Park, MD, PhD, Division of Gastroenterology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South KoreaRésumé |
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.)
Le texte complet de cet article est disponible en PDF.Abbreviations : AF, FCSEMS, FE, PEP
Plan
| DISCLOSURE: The following author disclosed a financial relationship relevant to this publication: Dr. Park provided the concept of anchoring flap of FCSEMS (M.I. Tech, Seoul, South Korea) for the prevention of stent migration. For this clinical trial, all stents were provided by the manufacturers (M.I. Tech, and Standard Sci Tech, Seoul, South Korea) free of charge. All other authors have no financial relationships relevant to this publication. |
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| If you would like to chat with an author of this article, you may contact Dr Park at dhpark@amc.seoul.kr. |
Vol 73 - N° 1
P. 64-70 - janvier 2011 Retour au numéro
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