TY - JOUR
T1 - Combination of biodegradable stent placement and single-dose brachytherapy is associated with an unacceptably high complication rate in the treatment of dysphagia from esophageal cancer
AU - Hirdes, Meike M. C.
AU - van Hooft, Jeanin E.
AU - Wijrdeman, Harm K.
AU - Hulshof, Maarten C. C. M.
AU - Fockens, Paul
AU - Reerink, Onne
AU - van Oijen, Martijn G. H.
AU - van der Tweel, Ingeborg
AU - Vleggaar, Frank P.
AU - Siersema, Peter D.
PY - 2012
Y1 - 2012
N2 - 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. (Gastrointest Endosc 2012;76:267-74.)
AB - 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. (Gastrointest Endosc 2012;76:267-74.)
U2 - https://doi.org/10.1016/j.gie.2012.04.442
DO - https://doi.org/10.1016/j.gie.2012.04.442
M3 - Article
C2 - 22695208
SN - 0016-5107
VL - 76
SP - 267
EP - 274
JO - Gastrointestinal Endoscopy
JF - Gastrointestinal Endoscopy
IS - 2
ER -