Abstract
BACKGROUND For the palliative treatment of dysphagia, esophageal stent placement provides immediate improvement, whereas brachytherapy offers better long-term relief. OBJECTIVE To evaluate safety and efficacy of concurrent brachytherapy and biodegradable stent placement. DESIGN Prospective, single-arm study. SETTING Two tertiary-care referral centers. PATIENTS Nineteen consecutive patients with significant dysphagia resulting from unresectable esophageal cancer, with a life expectancy of more than 3 months. INTERVENTION Single-dose brachytherapy (12 Gy) on day 1 followed by biodegradable stent placement on day 2. MAIN OUTCOME MEASUREMENTS Intervention-related major complications (determined by an expert panel) and dysphagia. RESULTS Nineteen patients (13 men, median age 66 years [interquartile range (IQR) 59-71] years) were included; 7 patients (37%) also received palliative chemotherapy. After inclusion of 19 patients, the study was ended prematurely because the safety threshold was exceeded. In total, 28 major complications occurred in 17 patients (89%). In 9 patients (47%), major complications were determined intervention-related (severe retrosternal pain with or without vomiting [n = 6], hematemesis [n = 1], recurrent dysphagia [n = 2]. Dysphagia scores decreased significantly from a median of 3 (IQR 3-4) to a median of 1 (IQR 0-3) after 1 month (P < .001). Despite adequate luminal patency in 17 patients (89%), normal diet could not be tolerated in 7 patients (37%) because of retrosternal pain and vomiting. LIMITATIONS Lack of routine endoscopy or contrast esophagram to evaluate recurrent dysphagia during follow-up. CONCLUSION Despite restoration of luminal patency, a combined treatment of brachytherapy and biodegradable stent placement cannot be recommended for the palliative treatment of esophageal cancer because of an unacceptably high intervention-related major complication rate.
