Biodegradable stent or balloon dilatation for benign oesophageal stricture: Pilot randomised controlled trial

AIM: To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures.

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.