Efficacy and safety of the new WallFlex enteral stent in palliative treatment of malignant gastric outlet obstruction (DUOFLEX study): a prospective multicenter study

Background: Gastric outlet obstruction (GOO) is most commonly a complication of advanced distal gastric, periampullary, or duodenal malignancy. Palliation of obstruction is the primary aim of treatment in most of these patients. Self-expandable metal stents have emerged as an effective treatment option. Objective: Our purpose was to investigate the efficacy and safety of a newly developed enteral metal stent (WallFlex). Design: Prospective multicenter cohort study. Setting: Three tertiary referral centers (2 academic). Patients: Fifty-one consecutive patients with symptomatic malignant GOO from January 2005 to February 2006. Intervention: Placement of a self-expandable metallic stent (WallFlex). Main Outcome Measurements: The primary end point was defined as improvement of the GOO scoring system for the remainder of the patients' lives. Secondary end points focused on efficacy and safety and global quality of life. Results: The Gastric Outlet Obstruction Scoring System score improved (P < .001), the body mass index decreased (P < .001), and the World Health Organization performance score improved (P = .002) when the score before stenting was compared with the mean score until death. Global quality of life did not improve. Technical and clinical success was achieved in 98% and 84% of the patients. Median survival was 62 days (75% alive at 35 days, 25% alive at 156 days). Median stent patency was 307 days (75% functional at 135 days, 25% functional at 470 days). Stent dysfunction was proved in 7 patients (14%), migration in 1 (2%), and tumor overgrowth or ingrowth in 6 (12%). Limitations: Lack of a control group. Conclusion: Placement of a WallFlex enteral stent in patients with nonresectable malignant GOO is safe and provides a statistically significant and clinically relevant relief of obstructive symptoms with a low need for reintervention.

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