USE OF THE 25 MM FLANGED ESOPHAGEAL Z-STENT FOR MALIGNANT DYSPHAGIA -A PROSPECTIVE MULTICENTER TRIAL

Background: An initial multicenter study using a 21 mm flanged esophag eal Z stent demonstrated excellent palliation but an 11% immediate com plication rate at placement and a 27% migration rate at 1 month. This North American multicenter trial prospectively studied a 25 mm flanged Z stent to define its palliative ability and whether the increased di ameter affected placement or migration problems. Methods: Fifty patien ts who had esophageal 2 stents at seven university or regional referra l hospitals were prospectively studied. Indications for prosthesis pla cement, previous therapy, patient demographics, incidence of concomita nt tracheoesophageal fistula, and degree of dysphagia were defined, as were procedural and subsequent stent-related problems, survival times , the ability to occlude a tracheoesophageal fistula, and subsequent d egree of dysphagia. Results: Twenty-four patients had infiltrating mal ignancy (16 exophytic and 10 extrinsic), 9 of whom had concomitant tra cheoesophageal fistulas. Ten patients (20%) had misplaced stents requi ring retrieval and replacement, 12 patients (24%) had subsequent stent -related problems including exsanguination (2), aspiration (3), tumor overgrowth (3), and postplacement migration (4) (8%). There was statis tically significant improvement: in prestent versus poststent dysphagi a and two thirds of patients had complete occlusion of their tracheoes ophageal fistula. Conclusions: Redesign of the esophageal 2, stent has decreased the migration rate without increasing placement or subseque nt erosion problems. Its efficacy appears comparable to the currently marketed 2 stent for the palliation of malignant dysphagia and occlusi on of tracheoesophageal fistula.