Ra. Kozarek et al., USE OF THE 25 MM FLANGED ESOPHAGEAL Z-STENT FOR MALIGNANT DYSPHAGIA -A PROSPECTIVE MULTICENTER TRIAL, Gastrointestinal endoscopy, 46(2), 1997, pp. 156-160
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.