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

Radiofrequency ablation of Barrett's columnar lined oesophagus and squamous dysplasia: multicentre trial with long term follow up using a central database

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN93069556
Enrollment
1000
Registered
2013-06-14
Start date
2008-03-31
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophageal Cancer/ Barrett's Oesophagus Cancer Malignant neoplasm of oesophagus

Interventions

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 e

Sponsors

Joint UCLH/UCL Biomedical Research Unit (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Ability of aneuploidy and other molecular changes to predict success or failure of this therapy.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026