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).

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.).