Effectiveness and safety of a newly designed partially covered tracheal metallic Y-shaped stent for the treatment of high cervical gastro-tracheal or tracheo-esophageal fistula: A retrospective observational study.

ABSTRACT: The aim of this study was to evaluate the effectiveness and safety of a partially covered metallic tracheal Y-shaped stent for the treatment of high cervical gastro-tracheal fistula (GTF) and tracheo-esophageal fistula (TEF). From January 2017 to January 2019, 16 patients with high cervical GTF and TEF received partially covered metallic Y-shaped stent placement under fluoroscopic guidance. The technical and clinical success rates, incidence of major complications, and survival outcomes were analyzed. Eastern Cooperative Oncology Group (ECOG) score and quality of life (SF-36 questionnaire) were compared pre and post stent placement. Technical and clinical success rates were 100% and 81.3%, respectively. Major complications (severe tumor ingrowth, mucostasis, hyperplastic granulation tissue) occurred in 7/16 (43.8%) patients. ECOG score and 5 of the 8 domains of the SF-36 (physical function, role physical, general health, vitality, social function) were significantly improved at 1 month after treatment (P < .01). During the median follow-up period of 8.3 months, 9 patients were alive. Median overall survival was 10.3 months (95% CI, 8.0-12.6). The newly designed partially covered tracheal Y-shaped stent appears to be effective and safe for treatment of high cervical GTF and TEF.