A national patient registry for radiofrequency ablation (RFA) for Barrett's oesophagus

ISRCTN	ISRCTN93069556
DOI	https://doi.org/10.1186/ISRCTN93069556
Protocol serial number	Protocol Version 3.1
Sponsor	Joint UCLH/UCL Biomedical Research Unit (UK)
Funder	BAARX Medical Inc. (USA)

Submission date: 12/06/2013
Registration date: 14/06/2013
Last edited: 08/02/2021

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-new-treatment-2-pre-cancerous-conditions-affecting-food-pipe-halo

Contact information

Dr Laurence Lovat
Scientific

University College London Hospitals NHS Trust
235 Euston Square
London
NW1 2BU
United Kingdom

Email	l.lovat@uclh.nhs.uk

Study information

Primary study design	Observational
Study design	Prospective multi-centre patient registry
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Radiofrequency ablation of Barrett's columnar lined oesophagus and squamous dysplasia: multicentre trial with long term follow up using a central database
Study objectives	The aim of this prospective, multi-centre patient registry study is to provide a tool for participating physician investigators to collect outcome data related to the use of the HALO Ablation Systems. We hypothesise that RFA is safe and effective in treating patients with dysplasia arising in Barrett's oesophagus and will maintain a durable response.
Ethics approval(s)	National Research Ethics Service (NRES), ref: 08/H0714/27
Health condition(s) or problem(s) studied	Oesophageal Cancer/ Barrett's Oesophagus
Intervention	HALO radiofrequency ablation (HALO RFA) The study collects the outcomes of patients undergoing the intervention which is RFA. The study collects not just demographic data on patients eligible for RFA treatment but also the effectiveness of the treatment in curing them of early oesophageal neoplasia. The study collates the number of procedures required to get to this point but also examines the reasons why we fail in a minority of patients so we can try understand these patients to help improve our practice and streamline our approach to them.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Endoscopic clearance rate for Barrett's esophagus. Percentage of patients with no endoscopically visible Barrett's oesophagus at 1 year follow-up 2. Histological clearance rate for intestinal metaplasia. Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up 3. Histological clearance rate for columnar dysplasia. Percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up 4. Sub-squamous intestinal metaplasia. Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface
Key secondary outcome measure(s)	Ability of aneuploidy and other molecular changes to predict success or failure of this therapy.
Completion date	31/03/2028

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	21 Years
Sex	All
Target sample size at registration	1000
Key inclusion criteria	1. Patients will be recruited from those referred for ablative management of Barrett's oesopahgus or squamous dysplasia with HALO RFA 2. Patients must have no contraindications to endoscopy 3. Males and non-pregnant females over the age of 21 years. Female patients who are pre-menopausal must practice a medically acceptable form of contraception. 4. Patients must sign an informed consent form
Key exclusion criteria	1. Presence of invasive carcinoma of the oesophagus 2. Patients in whom endoscopy is contraindicated 3. Patients with oesophageal varices 4. Previous radiotherapy 5. Patients who have undergone Hellers myotomy 6. Pregnant females 7. People under the age of 21 years
Date of first enrolment	31/03/2008
Date of final enrolment	30/09/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University College London Hospitals NHS Trust

London
NW1 2BU
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	01/08/2015		Yes	No
Results article	results	05/02/2021	08/02/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

08/02/2021: Publication reference added.
31/05/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2018 to 30/09/2027.
2. The overall trial end date was changed from 31/03/2018 to 31/03/2028.