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.
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.
Authors: E Coron; G David; S Lecleire; J Jacques; A Le Sidaner; T Barrioz; D Coumaros; C Volteau; B Vedrenne; P Bichard; C Boustière; Y Touchefeu; J Brégeon; F Prat; M Le Rhun Journal: Endosc Int Open Date: 2016-06
Authors: Douglas Adamson; Jane Blazeby; Catharine Porter; Christopher Hurt; Gareth Griffiths; Annmarie Nelson; Bernadette Sewell; Mari Jones; Martina Svobodova; Deborah Fitzsimmons; Lisette Nixon; Jim Fitzgibbon; Stephen Thomas; Anthony Millin; Tom Crosby; John Staffurth; Anthony Byrne Journal: Health Technol Assess Date: 2021-05 Impact factor: 4.014
Authors: W F Kappelle; J E van Hooft; M C W Spaander; F P Vleggaar; M J Bruno; F Maluf-Filho; A Bogte; E van Halsema; P D Siersema Journal: Endosc Int Open Date: 2019-01-18