A national patient registry for radiofrequency ablation (RFA) for Barrett's oesophagus
| ISRCTN | ISRCTN93069556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93069556 |
| Secondary identifying numbers | Protocol Version 3.1 |
- 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
Contact information
Dr Laurence Lovat
Scientific
Scientific
University College London Hospitals NHS Trust
235 Euston Square
London
NW1 2BU
United Kingdom
| l.lovat@uclh.nhs.uk |
Study information
| Study design | Prospective multi-centre patient registry |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 31/03/2008 |
| Completion date | 31/03/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
University College London Hospitals NHS Trust
London
NW1 2BU
United Kingdom
NW1 2BU
United Kingdom
Sponsor information
Joint UCLH/UCL Biomedical Research Unit (UK)
University/education
University/education
c/o Mr Philip Diamond
1st Floor Maple House
149 Tottenham Court Road
London
W1P 9LL
London
W1P 9LL
England
United Kingdom
| philip.diamond@uclh.nhs.uk | |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Industry
BAARX Medical Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
