Improved oral intake after palliative duodenal stenting for malignant obstruction: a prospective multicenter clinical trial.

Objectives: We sought to test the hypothesis that placement of a new nitinol duodenal self-expandable metallic stent (SEMS) for palliation of malignant gastroduodenal obstruction is effective and safe in allowing patients to tolerate an oral diet.

Methods: In a prospective multicenter study, SEMSs (Duodenal WallFlex, Boston Scientific) were placed to alleviate gastroduodenal obstruction in inoperable patients without the ability to tolerate solid food. The primary study end point was improvement in oral intake monitored according to the 4-point Gastric Outlet Obstruction Scoring System (GOOSS) up to 24 weeks after stent placement.

Results: Forty-three patients received SEMSs, which were successfully deployed on the first attempt in 41 cases (95%) and the second attempt in two (5%). Within 1 day and 7 days after SEMS placement, 52% and 75% of patients, respectively, benefited from a GOOSS increase > or =1. Resumption of solid food intake (GOOSS 2-3) was attained by 56% of patients within 7 days and 80% by 28 days. Of the patients attaining GOOSS 2-3, 48% remained on solid food until death or last follow-up. Device-related adverse events included stent occlusion/malfunction in 9% of patients and perforation in 5% of patients.

Conclusions: Duodenal WallFlex stent placement promptly improves oral intake in a majority of inoperable patients with malignant gastroduodenal obstruction. In approximately half the patients achieving GOOSS 2-3, the capacity for solid food intake endures until death or last follow-up.