PROSPECTIVE MULTICENTER TRIAL OF ESOPHAGEAL Z-STENT PLACEMENT FOR MALIGNANT DYSPHAGIA AND TRACHEOESOPHAGEAL FISTULA

Background: Conventional esophageal prosthesis placement has been asso ciated with a 6% to 8% perforation rate and numerous postplacement com plications. Expandable esophageal stents have been developed to preclu de the above but there are few studies that have prospectively defined clinical results and subsequent stent-related complications. Methods: All patients who underwent esophageal Z-stent placement at nine unive rsity or referral hospitals were prospectively assessed. Data collecte d included patient demographics, acute and subacute placement problems , the ability to occlude airway fistulas, prestent and poststent dysph agia scores, and patient survival. Results: Fifty-four of 56 patients (96%) with refractory dysphagia or malignant esophagoairway fistulae h ad 73 Z-stents successfully inserted. Initial distal deployment occurr ed in 13% of the patients and an additional 17% required balloon dilat ion to achieve maximal diameter. Acute placement complications occurre d in 11% of patients and included severe pain (3), bleeding from necro tic tumor (2), and hiatal hernia intussusception (1). No perforations occurred. Eight of 11 patients (73%) had complete tracheoesophageal fi stula occlusion and mean dysphagia score (+/-SD) improved from 2.6 (0. 7) to 1.1 (1.2) (p < 0.01). Fifteen stents (27%) had delayed migration at a mean of 1 month and 3 required surgery for retrieval. Three pati ents had ultimate stent erosion resulting in bleeding in 2 (exsanguina tion 1) or fistula (treated with a conventional stent). Conclusions: T he authors conclude that esophageal Z-stents can be placed safely and successfully in the majority of patients. The tendency of distal deplo yment during placement and subsequent migration problems at a time dis tant from placement in a patient subset deserve attention and are curr ently being addressed.