title: Biodegradable stent or balloon dilatation for benign oesophageal stricture: pilot randomised controlled trial.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Anjan Dhar, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Co. Durham DL14 6AD, United Kingdom.
authors.forename: Anjan
authors.initials: A
authors.lastname: Dhar
authors.affiliation: Anjan Dhar, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Co. Durham DL14 6AD, United Kingdom.
authors.forename: Helen
authors.initials: H
authors.lastname: Close
authors.affiliation: Anjan Dhar, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Co. Durham DL14 6AD, United Kingdom.
authors.forename: Yirupaiahgari K
authors.initials: YK
authors.lastname: Viswanath
authors.affiliation: Anjan Dhar, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Co. Durham DL14 6AD, United Kingdom.
authors.forename: Colin J
authors.initials: CJ
authors.lastname: Rees
authors.affiliation: Anjan Dhar, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Co. Durham DL14 6AD, United Kingdom.
authors.forename: Helen C
authors.initials: HC
authors.lastname: Hancock
authors.affiliation: Anjan Dhar, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Co. Durham DL14 6AD, United Kingdom.
authors.forename: A Deepak
authors.initials: AD
authors.lastname: Dwarakanath
authors.affiliation: Anjan Dhar, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Co. Durham DL14 6AD, United Kingdom.
authors.forename: Rebecca H
authors.initials: RH
authors.lastname: Maier
authors.affiliation: Anjan Dhar, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Co. Durham DL14 6AD, United Kingdom.
authors.forename: Douglas
authors.initials: D
authors.lastname: Wilson
authors.affiliation: Anjan Dhar, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Co. Durham DL14 6AD, United Kingdom.
authors.forename: James M
authors.initials: JM
authors.lastname: Mason
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D003679:Deglutition; D003680:Deglutition Disorders / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D004106:Dilatation; D004940:Esophageal Stenosis / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D004945:Esophagoscopy / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011474:Prosthesis Design; D011788:Quality of Life; D020127:Recovery of Function; D012008:Recurrence; D019233:Retreatment; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
keywords: Benign oesophageal stricture; Biodegradable stent; Dysphagia; Endoscopic balloon dilatation; Pilot study; Randomised controlled trial