A pilot study of fully covered self-expandable metal stents prior to neoadjuvant therapy for locally advanced esophageal cancer.

Self-expandable metal stents (SEMS) have been mostly reserved for palliation of dysphagia because of advanced esophageal cancer. Fully covered SEMS (FCSEMS) (ALIMAXX-E, Alveolus Inc, Charlotte, NC, USA) offer the choice of removability if complications occur or maximum therapeutic benefit is achieved. To our knowledge, their use has not been studied in patients undergoing neoadjuvant therapy. The objectives of this study were the following: (i) to evaluate whether FCSEMS are useful in patients receiving neoadjuvant therapy; and (ii) to assess ease of removability and tissue reaction to FCSEMS. FCSEMS (ALIMAXX-E, Alveolus Inc) were deployed in consecutive patients with locally advanced esophageal cancer over a period of 14 months. All patients were referred for neoadjuvant chemoradiation therapy after stenting. Dysphagia scores were assessed at 0 month, 1 month, 3 months, and 6 months. Barium swallow and endoscopy were performed for new symptoms and follow-up. Eleven patients were treated with FCSEMS prior to neoadjuvant therapy (mean age 60.5 years, 55% white, 91% male). All but one stent were successfully placed. Strictures were located in the upper esophagus (n= 1), middle esophagus (n= 4), lower esophagus (n= 2), and gastroesophageal junction (n= 4). Dysphagia was significantly improved at 1 month (mean difference 3.12; 2.53-3.79 95% confidence interval [CI]), 3 months (mean difference 2.86, 2.19-3.53 95% CI), and 6 months (mean difference 2.56, 1.79-3.34 95% CI) compared with baseline. Three patients (27%) experienced chest pain or heartburn immediately following deployment. Only two patients ultimately underwent surgical resection. The others were diagnosed with metastatic disease prior to surgery, had disease progression in spite of neoadjuvant treatment, or died with the stent in place. Three patients developed delayed complications: recurrent dysphagia (n= 2) and tracheal-esophageal fistula (n= 1). Eight (73%) stents were subsequently removed, one because of complication (tracheal-esophageal fistula), one because of migration (recurrent dysphagia), one was incorrectly deployed, and five were felt to have satisfied their purpose. Stents remained in place for a mean duration of 100.36 days (range 0-105, median 84). Removal was characterized as very easy in all cases. Upon removal, ulcerations at the proximal or distal edge of stents were noted in six patients (75%), polyps in four (50%), and granulation in six (75%). One stent (13%) became embedded but was easily lifted from tissue. There were no perforations. Neoadjuvant treatment may have contributed to improvement in dysphagia scores. FCSEMS can be used to re-establish esophageal luminal patency in patients undergoing neoadjuvant therapy for locally advanced esophageal cancer, resulting in significant improvement in dysphagia over baseline. Tissue reaction to stents occurs but does not appear to impair removability.