Stenting in benign oesophageal stricture

ISRCTN	ISRCTN05817794
DOI	https://doi.org/10.1186/ISRCTN05817794
Protocol serial number	PB-PG-1208-17025
Sponsor	County Durham and Darlington NHS Foundation Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-1208-17025)

Submission date: 28/07/2010
Registration date: 26/08/2010
Last edited: 05/02/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anjan Dhar
Scientific

Consultant Gastroenterologist
Department of Gastroenterology
Darlington Memorial and Bishop Auckland Hospitals
County Durham and Darlington NHS Foundation Trust
Cockton Hill Road
Bishop Auckland
DL14 6AD
United Kingdom

Phone	+44 (0)1388 455170
Email	anjan.dhar@cddft.nhs.uk

Study information

Primary study design	Interventional
Study design	Two-arm 1:1 prospective randomised controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Biodegradable stent in benign oesophageal stricture compared to standard balloon dilatation treatment: a two-arm 1:1 randomised clinical trial
Study acronym	BESST
Study objectives	This pilot study addresses the potential effectiveness and cost-effectiveness of biodegradable stent placement in patients with benign oesophageal stricture. The study will determine the feasibility and utility of a randomised controlled trial design comparing biodegradable oesophageal stent or standard dilatation in symptomatic adult patients diagnosed with refractory oesophageal stricture. The primary endpoint will be ability to swallow, assessed by a five point dysphagia score (assessed by a blinded observer at baseline, 3, 6 and 12 months). Secondary end points will include the acceptability of procedures and overall care to patients, the number of repeat endoscopic procedures (therapeutic and diagnostic), adverse events (including hospital admissions), quality of life assessed physically using surrogate markers such as weight and serum albumin and by generic quality of life assessment (EuroQol EQ-5D) and economic analysis. Economic analysis will be conducted from an NHS perspective. Stochastic cost-effectiveness analysis will use patient-level, within-trial (1 year) cost and quality-adjusted life-year (QALY) data. Modelling using probabilistic methods will explore extrapolations of benefits beyond one-year. The summative aim is to show the potential value of a new treatment option which may improve the quality of life for patients and be a cost-effective alternative for the NHS. The proposed pilot study is an essential step to establish the need for a larger trial and to provide the necessary evidence base to inform patients and the NHS.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Benign oesophageal strictures
Intervention	The study will involve endoscopic interventions of balloon dilatation with or without fluroscopy in one (control) arm and placement of a biodegradable stent in the other arm. The treatment in each arm is a one time procedure. Patients will be followed up for a period of 12 months after the endoscopic intervention in each arm.
Intervention type	Other
Primary outcome measure(s)	The average dysphagia (swallowing) score response over 12 months
Key secondary outcome measure(s)	1. Acceptibility of procedures to patients 2. Number of repeat endoscopic procedures 3. Frequency of refractory disease 4. Adverse events 5. Quality of life assessed physically using surrogate markers of weight, serum albumin and by generic quality of life assessment (EuroQol EQ-5D) 6. Patient level, NHS perspective, cost and cost-effectiveness analysis Measured at 3, 6 and 12 months following the endoscopic intervention in both arms
Completion date	31/10/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Signed written informed consent 2. Confirmed diagnosis of benign oesophageal stricture 3. Adults aged between 18 and 75 years, either sex 4. At least one previous oesophageal dilatation for management of their benign oesophageal stricture
Key exclusion criteria	1. Patients who do not fulfil the inclusion criteria 2. Patients with high strictures 3. Pregnant patients 4. Receiving anti-coagulants 5. Diagnosis or oesophageal cancer 6. Diagnosis of a terminal disease 7. A history of any medical illness which, in the Investigator's discretion would inhibit the patient's participation 8. Women of child bearing potential who refuse to use adequate contraception for three months post-intervention
Date of first enrolment	01/11/2010
Date of final enrolment	31/10/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Darlington Memorial and Bishop Auckland Hospitals

Department of Gastroenterology
Bishop Auckland
DL14 6AD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/12/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

05/02/2016: Publication reference added