Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Laurence Lovat
ORCID ID
Contact details
University College London Hospitals NHS Trust
235 Euston Square
London
NW1 2BU
United Kingdom
-
l.lovat@uclh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol Version 3.1
Study information
Scientific title
Radiofrequency ablation of Barrett's columnar lined oesophagus and squamous dysplasia: multicentre trial with long term follow up using a central database
Acronym
Study hypothesis
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
National Research Ethics Service (NRES), ref: 08/H0714/27
Study design
Prospective multi-centre patient registry
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
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
Secondary outcome measures
Ability of aneuploidy and other molecular changes to predict success or failure of this therapy.
Overall trial start date
31/03/2008
Overall trial end date
31/03/2028
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant 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
Recruitment start date
31/03/2008
Recruitment end date
30/09/2027
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London Hospitals NHS Trust
London
NW1 2BU
United Kingdom
Sponsor information
Organisation
Joint UCLH/UCL Biomedical Research Unit (UK)
Sponsor details
c/o Mr Philip Diamond
1st Floor Maple House
149 Tottenham Court Road
London
W1P 9LL
London
W1P 9LL
United Kingdom
-
philip.diamond@uclh.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
BAARX Medical Inc. (USA)
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25539672