Original Article
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World J Gastroenterol. Dec 28, 2014; 20(48): 18199-18206
Published online Dec 28, 2014. doi: 10.3748/wjg.v20.i48.18199
Biodegradable stent or balloon dilatation for benign oesophageal stricture: Pilot randomised controlled trial
Anjan Dhar, Helen Close, Yirupaiahgari K Viswanath, Colin J Rees, Helen C Hancock, A Deepak Dwarakanath, Rebecca H Maier, Douglas Wilson, James M Mason
Anjan Dhar, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Co. Durham DL14 6AD, United Kingdom
Helen Close, Helen C Hancock, Rebecca H Maier, Douglas Wilson, James M Mason, Durham Clinical Trials Unit, School of Medicine, Pharmacy and Health, Durham University, Queen’s Campus, Wolfson Research Institute, University Boulevard, Stockton-on-Tees TS17 6BH, United Kingdom
Yirupaiahgari K Viswanath, Department of Surgery, James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW, United Kingdom
Colin J Rees, Department of Gastroenterology, South Tyneside Hospitals NHS Foundation Trust, Harton Lane, South Shields NE34 0PL, United Kingdom
A Deepak Dwarakanath, Department of Gastroenterology, University Hospitals of North Tees, Hardwick, Stockton on Tees TS19 8PE, United Kingdom
Author contributions: Dhar A, Close H and Mason JM designed the research; Dhar A, Viswanath YK, Rees CJ and Dwarakanath AD performed the research; Mason JM and Wilson D analysed data; Mason JM wrote the paper; Dhar A, Close H, Viswanath YK, Rees CJ, Hancock HC, Dwarakanath AD, Maier RH, Wilson D and Mason JM read and approved the final manuscript.
Supported by National Institute for Health Research under its Research (NIHR) for Patient Benefit Programme, No. PB-PG-1208-17025; the views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health
Correspondence to: Anjan Dhar, DM, MD, FRCPE, AGAF, Cert.Med.Ed, FHEA, Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Cockton Hill Road, Co. Durham DL14 6AD, United Kingdom. anjan.dhar@cddft.nhs.uk
Telephone: +44-1388-455170 Fax: +44-1388-455051
Received: May 8, 2014
Revised: July 7, 2014
Accepted: September 5, 2014
Published online: December 28, 2014
Processing time: 243 Days and 4.2 Hours
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.

Keywords: Benign oesophageal stricture; Biodegradable stent; Endoscopic balloon dilatation; Pilot study; Randomised controlled trial; Dysphagia

Core tip: Benign oesophageal strictures are managed by endoscopic dilatation using balloons or bougies, often requiring costly repeat procedures. Biodegradable stents do not usually require removal and may reduce the need for repeated endoscopy. This pilot multi-site randomized study demonstrates that stenting was associated with greater dysphagia, co-medication and adverse events. The oesophageal tract has somatic sensitivity and the process of the stent dissolving, possibly unevenly, might promote discomfort or reflux. Groups were comparable at baseline and findings are statistically significant but patient numbers were small. Rigorously conducted and adequately powered trials are needed before widespread adoption of this technology.