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.
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.
['Lee|Hyun Woo|HW|', 'Moon|Jong Ho|JH|', 'Lee|Yun Nah|YN|', 'Lee|Tae Hoon|TH|', 'Choi|Moon Han|MH|', 'Cha|Sang-Woo|SW|', 'Cho|Young Deok|YD|', 'Park|Sang-Heum|SH|']
D000368:Aged D000369:Aged, 80 and over D002760:Cholangiopancreatography, Endoscopic Retrograde D002779:Cholestasis D003251:Constriction, Pathologic D004067:Digestive System Neoplasms D004322:Drainage D005260:Female D005548:Foreign-Body Migration D006801:Humans D008297:Male D008670:Metals D008875:Middle Aged D011474:Prosthesis Design D011475:Prosthesis Failure D012189:Retrospective Studies D015607:Stents D016896:Treatment Outcome
malignant biliary stricture covered self-expandable metal stent stent migration periampullary cancer