Oesophageal Cancer/ Barrett's Oesophagus Cancer Malignant neoplasm of oesophagus
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| Ability of aneuploidy and other molecular changes to predict success or failure of this therapy. | — |
Countries
United Kingdom