SILICONE-COVERED WALLSTENT PROTOTYPES FOR PALLIATION OF MALIGNANT ESOPHAGEAL OBSTRUCTION AND DIGESTIVE-RESPIRATORY FISTULAS

Background: Endoscopic palliation of malignant esophageal obstruction with uncovered self-expanding metal stents has been shown to have fewe r complications than with conventional plastic stents. The addition of a membrane might prevent tumor ingrowth and allow treatment of digest ive-respiratory fistulas. We report the clinical experience with a pro totype silicone membrane covered self-expanding metal stent. Methods: Twenty-three silicone membrane covered Wallstent prototypes were used in 21 patients with dysphagia due to inoperable malignant tumors invol ving the esophagus and cardia. Results: Stent implantation was technic ally successful in all patients. There were no procedure-related perfo rations or deaths. The prototype stent was successful in sealing seven of the eight (87.5%) digestive-respiratory fistulas. As a group, the mean dysphagia grade improved significantly after stent placement (4.8 +/- 0.9 vs 3.4 +/- 1.6, p < 0.0005). However, 9 of 21 (42.9%) patient s experienced no improvement in their dysphagia. Complications occurre d in 13 of 21 (61.9%) patients. Tumor ingrowth was not observed in any patient. Conclusions: The prototype covered self-expanding metal sten t was effective in sealing digestive-respiratory fistulas and provided palliation of dysphagia in slightly more than one half of the patient s studied. A great deal has been learned from the preliminary experien ce, which has led to design modifications. The utility of the commerci ally available device should be evaluated in further prospective clini cal trials.