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Biodegradable stent or balloon dilatation for benign oesophageal stricture : pilot randomised controlled trial.
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Dhar, Anjan, Close, Helen, Viswanath, Yirupaiahgari K., Rees, Colin J., Hancock, Helen C., Dwarakanath, A Deepak, Maier, Rebecca H., Wilson, Douglas and Mason, James (2014) Biodegradable stent or balloon dilatation for benign oesophageal stricture : pilot randomised controlled trial. World Journal of Gastroenterology, 20 (48). pp. 18199-206. ISSN 1007-9327.
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Official URL: http://dx.doi.org/10.3748/wjg.v20.i48.18199
Abstract
Aim: To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures.
Methods: This British multi-site study recruited seventeen symptomatic adult patients with refractory strictures. Patients were randomised using a multicentre, blinded assessor design, comparing a biodegradable stent (BS) with endoscopic dilatation (ED). The primary endpoint was the average dysphagia score during the first 6 mo. Secondary endpoints included repeat endoscopic procedures, quality of life, and adverse events. Secondary analysis included follow-up to 12 mo. Sensitivity analyses explored alternative estimation methods for dysphagia and multiple imputation of missing values. Nonparametric tests were used.
Results: Although both groups improved, the average dysphagia scores for patients receiving stents were higher after 6 mo: BS-ED 1.17 (95%CI: 0.63-1.78) P = 0.029. The finding was robust under different estimation methods. Use of additional endoscopic procedures and quality of life (QALY) estimates were similar for BS and ED patients at 6 and 12 mo. Concomitant use of gastrointestinal prescribed medication was greater in the stent group (BS 5.1, ED 2.0 prescriptions; P < 0.001), as were related adverse events (BS 1.4, ED 0.0 events; P = 0.024). Groups were comparable at baseline and findings were statistically significant but numbers were small due to under-recruitment. The oesophageal tract has somatic sensitivity and the process of the stent dissolving, possibly unevenly, might promote discomfort or reflux.
Conclusion: Stenting was associated with greater dysphagia, co-medication and adverse events. Rigorously conducted and adequately powered trials are needed before widespread adoption of this technology.
Item Type: | Journal Article | ||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | World Journal of Gastroenterology | ||||||
Publisher: | Baishideng Publishing Group Co., Limited | ||||||
ISSN: | 1007-9327 | ||||||
Official Date: | 28 December 2014 | ||||||
Dates: |
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Volume: | 20 | ||||||
Number: | 48 | ||||||
Page Range: | pp. 18199-206 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published |
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