Abstract

BACKGROUND: Different types of self-expanding metallic stents are available for the palliative treatment of malignant strictures at the gastroesophageal junction. To overcome some of the disadvantages in the design of these metallic stents, we designed a silicone-covered self-expanding antireflux metallic stent that can prevent free gastroesophageal reflux after stent placement. METHODS: Seventeen silicone-covered antireflux prototypes were used in 17 patients with dysphagia caused by inoperable malignant tumors involving the gastroesophageal junction. RESULTS: Stent implantation was technically successful in all 17 patients. There were no procedure-related perforations or deaths. As a group, the mean dysphagia grade improved significantly (2.56 ± 0.49 vs 1.00 ± 0.51, P < 0.001) and the mean lumenal diameter was greatly increased (4.11 ± 1.02 vs 14.72 ± 4.01, P < 0.001) after stent placement. Ten patients received ambulatory 24-h esophageal pH monitoring and compared with the healthy volunteers, there were no postprocedural abnormal gastroesophageal refluxes in any patient. Three patients had substantial chest pain requiring long-term analgesics. No other complications were observed. CONCLUSIONS: The newly developed self-expanding antireflux metallic stent is safe and effective for use in the palliation of dysphagia caused by malignant strictures at the gastroesophageal junction. A larger patient population would be required to give valid conclusions.

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