Condition category
Digestive System
Date applied
28/07/2010
Date assigned
26/08/2010
Last edited
05/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anjan Dhar

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PB-PG-1208-17025

Study information

Scientific title

Biodegradable stent in benign oesophageal stricture compared to standard balloon dilatation treatment: a two-arm 1:1 randomised clinical trial

Acronym

BESST

Study hypothesis

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

Not provided at time of registration

Study design

Two-arm 1:1 prospective randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

The average dysphagia (swallowing) score response over 12 months

Secondary outcome measures

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

Overall trial start date

01/11/2010

Overall trial end date

31/10/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

01/11/2010

Recruitment end date

31/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Darlington Memorial and Bishop Auckland Hospitals
Department of Gastroenterology
Bishop Auckland
DL14 6AD
United Kingdom

Sponsor information

Organisation

County Durham and Darlington NHS Foundation Trust (UK)

Sponsor details

c/o Dr Yan Yiannakou
Director of Research & Development
Research & Development Directorate
County Durham & Darlington NHS Foundation Trust
Pierremont Unit
Darlington Memorial Hospital
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
+44 (0)1325 743 737
yan.yiannakou@cddft.nhs.uk

Sponsor type

Government

Website

http://www.cddft.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-1208-17025)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25561787

Publication citations

Additional files

Editorial Notes

05/02/2016: Publication reference added