The most important risk factor for developing esophageal adenocarcinoma (EAC) is the presence of a Barrett esophagus (BE), a condition in which, due to chronic gastro-esophageal reflux, the epithelium of the distal esophagus has been replaced by columnar epithelium containing specialized intestinal metaplasia. Patients with low grade intraepithelial neoplasia (LGIN) are therefore kept under more close observation and/or undergo more frequent endoscopic surveillance (every 6 to 12 months). Endosc
Conditions
Interventions
Radiofrequency ablation of the Barrett’s segment.
Sponsors
Academic Medical Center (AMC) Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients in the age of 18-85 years with LGIN in a Barrett’s esophagus; 2. Last high resolution endoscopy with biopsies performed within 6 months prior to inclusion; 3. LGIN in biopsies obtained from the Barrett's esophagus in the preceding 18 months and after revision of the pathology slides by at least one of the study pathologists; 4. No endoscopically visible abnormalities during at least one high resolution endoscopy within 12 months prior to inclusion; 5. In case of endoscopic resection of visible abnormalities, the resection specimen may at the utmost contain LGIN, after revision by at least one of the study pathologists; 6. Informed written consent.
Exclusion criteria
Exclusion criteria: 1. Any endoscopic visual abnormality detected by high-resolution white light endoscopy; 2. High-grade intraepithelial neoplasia or invasive cancer, confirmed by at least one of the study pathologists, in any of the biopsies obtained at endoscopies within 12 months prior to inclusion; 3. Any prior endoscopic treatment of HGD or invasive cancer in Barrett’s esophagus, confirmed by at least one of the study pathologists; 4. Any known secondary malignancy in active disease stage; 5. Estimated life-expectancy < 2 years; 6. Patients unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of high-grade intraepithelial neoplasia and early cancer during two year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of total histological eradication of LGIN; 2. Rate of total endoscopic eradication of Barrett’s mucosa; 3. Rate of total histological eradication of Barrett’s mucosa; 4. Number of procedures and costs; 5. Acute and late complications of RFA; 6. Percentage of surface regression of Barrett’s epithelium; 7. Rate of quality of life; 8. Oncogenetic alterations. | — |
Contacts
Public ContactJ.J.G.H.M. Bergman
Academic Medical Center Bldg. C2-210, Meibergdreef
Outcome results
None listed