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.
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