Management of malignant gastric outlet obstruction with a modified triple-layer covered metal stent.

BACKGROUND

A high incidence of migration with covered metal stents has been reported in malignant gastric outlet obstruction (GOO). A newly modified, partially covered, triple-layer nitinol stent was developed that has a longer uncovered portion (5-15 mm) to prevent stent migration.

OBJECTIVE

To estimate the efficacy and safety of the modified covered, triple-layer metal stent.

DESIGN

Multicenter, prospective cohort study.

SETTING

Three tertiary referral centers.

PATIENTS

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.

INTERVENTIONS

Endoscopic placement of the modified covered, triple-layer metal stent.

MAIN OUTCOME MEASUREMENTS

The primary endpoint was to improve the GOO scoring system (GOOSS) score. Secondary endpoints were success rate, patency, and complications.

RESULTS

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.

LIMITATIONS

A single-arm study in tertiary-care centers.

CONCLUSIONS

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

UMIN000004566.).