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AIM:To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures.METHODS:This British multi-site study recruitedseventeen symptomatic adult patients with refractory strictures.Patients were randomisedus in gamulticentre,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 and12 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 dysphgia,co-medication and adverse events.Rigorously conducted and adequately powered trials are needed before widespread adoption of this technology.
AIM: To undertake a randomized pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures. METHODS: This British multi-site study recruited persons with symptomatic adult adults with refractory strictures. Pats were randomized in gamulticenter, 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 analyzes 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 o f life (QALY) estimates were similar for BS and ED patients at 6 and 12 mo. Concomitant use of gastrointestinal causes was greater in the stent group (BS 5.1, ED 2.0 prescriptions; P <0.001), as were related adverse events 1.4, ED 0.0 events; P = 0.024) .Groups were comparable at baseline and the study were able significant but numbers were small due to under-recruitment. The oesophageal tract has somatic sensitivity and the process of the stent dissolving, discomfort or reflux.CONCLUSION: Stenting was associated with greater dysphgia, co-medication and adverse events. Designed and adequately powered trials are needed before widespread adoption of this technology.