A new fully covered metal stent for the treatment of benign and malignant dysphagia: a prospective follow-up study

Background: Fully covered self-expandable metal stents (FCSEMSs) are increasingly being used for malignant and benign strictures. Particularly in the latter, FCSEMSs are known for their high migration rates. A new FCSEMS with a dog-bone shape and internal covering was developed to reduce migration risk. Objective: To evaluate recurrent dysphagia and safety of the new FC stent in benign and malignant esophageal disorders. Design: Prospective follow-up study. Setting: Tertiary referral center. Patients: Between November 2009 and February 2011, 48 consecutive patients (mean age 61 years, range 28-81 years) underwent FC stent placement for malignant (n = 33) or benign (n = 15) dysphagia. Intervention: FC stent placement. Main Outcome Measurements: Recurrent dysphagia and complications. Results: Indications for FC stent placement included esophageal cancer (n = 28), extrinsic malignant compression (n = 4), recurrent malignancy after esophagectomy (n = 1), and refractory benign esophageal stricture (n = 15). In malignant strictures, recurrent dysphagia occurred in 5 patients (15%) because of stent migration (n = 3), tissue overgrowth (n = 1), and acute edema (n = 1). In benign strictures, stents were prematurely removed in 9 (60%) patients because of stent migration (n = 5), tissue overgrowth (n = 3), and pain (n = 1). Recurrent dysphagia occurred in all patients after stent removal. Major complications occurred in 10 patients (30%) with malignant strictures and in 3 patients (20%) with benign strictures and included severe pain and/or vomiting (n = 8), fistula formation (n = 2), bleeding (n = 2), and aspiration pneumonia (n = 1). Limitation: Nonrandomized study design. Conclusion: Although the new FC stent effectively treats malignant dysphagia, it is associated with substantial major complications. In patients with refractory benign esophageal strictures, recurrent dysphagia occurs rapidly after removal of the new FC stent. (Gastrointest Endosc 2012;75:712-8.)