An antireflux stent versus conventional stents for palliation of distal esophageal or cardia cancer: a randomized clinical study.

BACKGROUND: Self-expandable metal stents placed across the esophagogastric junction for palliative treatment of malignant strictures may lead to gastroesophageal reflux and pulmonary aspiration. This study compared the effects of a Dua antireflux stent with those of a conventional stent.

METHODS: Patients with incurable cancer of the distal esophagus or gastric cardia were randomly assigned to receive an antireflux stent (n = 19) or a standard stent (n = 22) at nine Swedish hospitals during the period September 1, 2003 to July 31, 2005. Complications were recorded at clinical follow-up visits. Survival rates were assessed through linkage to the Population Register. Dysphagia, reflux symptoms, esophageal pain, dyspnea, and global quality of life were assessed as changes in mean scores between baseline and 1 month after stent insertion through validated questionnaires.

RESULTS: No technical problems occurred during stent placement in the 41 enrolled patients. Fewer patients with complications were observed in the antireflux stent group (n = 3) than in the standard group (n = 8), but no statistically significant difference was shown (p = 0.14). The survival rates were similar in the two groups (p = 0.99; hazard ratio, 1.0; 95% confidence interval, 0.5-2.0). The groups did not differ significantly in terms of studied esophageal or respiratory symptoms or quality of life. Clinically relevant improvement in dysphagia occurred in both groups. Dyspnea decreased after antireflux stent insertion (mean score change, -11), and increased after insertion of standard stent (mean score change, +21).

CONCLUSIONS: Antireflux stents may be used without increased risk of complications, mortality, esophageal symptoms, or reduced global quality of life. These results should encourage large-scale randomized trials that can establish potentially beneficial effects of antireflux stents.