Abstract
OBJECTIVES: This study is aimed at evaluating the efficacy and safety of the big end double-layer uncovered self-expanding metal stents (SEMS) for the treatment of gastric outlet obstruction (GOO) caused by distal stomach cancer. METHODS: Seventy three patients receiving big end double-layer uncovered SEMS for the treatment of GOO caused by distal gastric cancer will be included in this multicenter prospective clinical trial. The main outcome measures included the functional outcome, the complications, the reinterventional rates, the average treatment charges, and the mean survival time. Monthly telephone calls were needed to assess the food intake until the patients died. RESULTS: The technical and the clinical success rates were 98.6%. The stent obstruction caused by tumor ingrowth was observed in one patient (1.4%). The incidence of food impaction was 2.9% (2/70) and the reinterventional rate was 4.3% (3/70). However, stent migration and obstruction caused by overgrowth were not observed. No perforation and severe bleeding were observed. The median cost of endoscopic stenting and total hospitalization (including reinterventions) for the big end double-layer uncovered SEMS in this study was $2945 and $3408, respectively. The mean survival time was 212.5 days. CONCLUSIONS: The placement of big end double-layer uncovered SEMS is a safe and effective modality and has the potential to be one of the options for the treatment of GOO caused by the distal gastric cancer.