Usefulness of newly modified fully covered metallic stent of 12 mm in diameter and anti‐migration feature for periampullary malignant biliary strictures: Comparison with conventional standard metal stent

Abstract

Backgrounds Fully covered self‐expandable metal stent (FCSEMS) are preferred for distal malignant biliary stricture (MBS). However, stent migration is a major adverse event of FCSEMS, especially for far distal MBS. We evaluated the usefulness of newly modified FCSEMS (M‐FCSEMS) having 12 mm in diameter and anti‐migration feature to minimize stent migration compared with the conventional FCSEMS (C‐FCSEMS). Methods Total 102 patients were enrolled between January 2015 and September 2017 in this prospective comparative study; 50 were allocated to the M‐FCSEMS group and 52 to the C‐FCSEMS group. The primary outcome was stent migration, and the secondary outcomes were other adverse events, stent occlusion rate, and stent patency during the follow‐up period. Results The baseline characteristics of the two groups did not significantly differ. Endoscopic stent placement was technically successful in all patients. Stent migration occurred in 8.0% (4/50) of the patients in the M‐FCSEMS group and 23.1% (12/52) of those in the C‐FCSEMS group (P = 0.036). The other adverse events, including stent‐related pancreatitis and cholecystitis did not significantly differ between the two groups (P = 0.415). Stent occlusion occurred in 23.9% (11/46) of the patients in the M‐FCSEMS group and 37.5% (15/40) in the C‐FCSEMS group (P = 0.171). Stent patency was significantly longer in the M‐FCSEMS group than in the C‐FCSEMS group (228 vs 157 days, P = 0.048). Conclusions Modified FCSEMS with 12‐mm diameter and anti‐migration feature significantly decreased the risk of stent migration and had longer patency compared with C‐FCSEMS in patients with periampullary MBS.

Prolonged patency of fully covered self-expandable metal stents with an externally anchored plastic stent in distal malignant biliary obstruction

“…Although a significantly prolonged patency of FCSEMSs was reported in a meta-analysis, one major concern with FCSEMSs is their higher likelihood of stent migration than USEMSs [9]. Sev-eral prior studies have shown the antimigratory properties of an anchoring flap, partially covered design, or novel structure of the stent [10][11][12]; however, an increased chance of mucosal injury and potential bleeding during removal, or the unique design itself may be important limitations to be considered. On the other hand, the addition of an EPS to an FCSEMS appears to be a simple, safe, and effective method to confer an antimigration effect.…”

Feasibility and efficacy evaluation of metallic biliary stents eluting gemcitabine and cisplatin for extrahepatic cholangiocarcinoma

“…Finally, we used the suture strategy, which does not correspond to clinical practice, to decrease the rates of migration after stent insertion. More reasonable modifications can be applied for anti-migration, including a modified configuration with anchoring fins, flared ends, an anchoring flap, or a larger diameter[ 41 ].…”

Endoscopic ultrasound-guided gastroenterostomy using a novel dumbbell-shaped fully covered metal stent for afferent loop syndrome with long interluminal distance

“…Recently, a novel dumbbell-shaped fully covered self-expandable metal stent (FCSEMS) (Bonastent M-Intraductal; Standard SciTech, Seoul, Korea) has become available 4 . Its unique shape, with a diameter in the central saddle portion that is thinner (8 mm) than that of the proximal and distal portions (12 mm), provides comparable antimigration properties to the LAMS.…”