To estimate the efficacy and safety of the modified covered, triple-layer metal stent.
Multicenter, prospective cohort study.
Three tertiary referral centers.
Fifty consecutive patients (26 with pancreatic carcinoma, 14 with gastric carcinoma, 9 with cholangiocarcinoma, 1 with a metastatic node) who presented with symptomatic unresectable malignant GOO between April 2007 and March 2010.
Endoscopic placement of the modified covered, triple-layer metal stent.
The primary endpoint was to improve the GOO scoring system (GOOSS) score. Secondary endpoints were success rate, patency, and complications.
The median GOOSS score improved significantly (P < .0001) after stenting (from 0 to 3). The technical and clinical success rates were 100 % and 90 % , respectively. Stent occlusion by tumor overgrowth or ingrowth at the uncovered portion developed in 5 patients (10 % ). Asymptomatic stent migration occurred in 3 patients (6 % ) receiving chemotherapy at 95, 230, and 553 days after stent placement, but these patients tolerated solid food 68, 260, and 142 days after stent migration, respectively. Other complications occurred in 1 patient with insufficient expansion, cholangitis, and pancreatitis. No procedure-related deaths occurred.
A single-arm study in tertiary-care centers.
The modified covered, triple-layer metal stent was effective and safe for managing malignant GOO and can prevent tumor ingrowth and stent migration. (Clinical trial registration number: .)