Randomised controlled trial of surveillance and no surveillance for patients with Barrett's oesophagus

ISRCTN	ISRCTN54190466
DOI	https://doi.org/10.1186/ISRCTN54190466
ClinicalTrials.gov (NCT)	NCT00987857
Protocol serial number	HTA 05/12/01
Sponsor	Gloucestershire Royal NHS Foundation Trust (UK)
Funder	Health Technology Assessment Programme

Submission date: 27/12/2007
Registration date: 08/01/2008
Last edited: 01/07/2022

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-how-often-to-monitor-people-with-barretts-oesophagus

Contact information

Prof Hugh Barr
Scientific

Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Email	hugh.barr@nhs.net

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial of surveillance and no surveillance for patients with Barrett's oesophagus: BOSS (Barrett's Oesophagus Surveillance Study)
Study acronym	BOSS
Study objectives	Comparison of endoscopic surveillance verus no endoscopic surveillance for the prevention of early mortality and the development of oesophageal adenocarcinoma.
Ethics approval(s)	Submission pending as of 02/01/2008
Health condition(s) or problem(s) studied	Barrett's oesophagus
Intervention	Upper gastrointestinalendoscopy every 2 years for 10 years
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. All causes mortality 2. Death from adenocarcinoma 3. Development of treatable adenocarcinoma Duration of follow-up: 10 years
Key secondary outcome measure(s)	1. Quality of life: Reflux Questionnaire and EQ50 Quality of Life Questionnaire at yearly intervals by post 2. Cost effectiveness of endoscopy
Completion date	30/06/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	2500
Total final enrolment	3520
Key inclusion criteria	Patients over 18 with endoscopic and histologically proven barrett's oesophagus greater than 1 cm
Key exclusion criteria	1. Unable to give consent 2. Unable to tolerate upper gastrointestinal endoscopy
Date of first enrolment	01/09/2009
Date of final enrolment	30/06/2022

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Gloucestershire Royal Hospital

Gloucester
GL1 3NN
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/09/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

01/07/2022: The following changes were made to the trial record:
1. The contact email was updated.
2. The total final enrolment was added.
13/02/2020: ClinicalTrials.gov number added.
15/04/2016: Publication reference added.