Barrett?s esophagus Digestive System Barrett's oesophagus
Conditions
Interventions
Patients who agree to participate in the study will be randomized to one of the two following therapies:
Group 1: Omeprazole 40 mg/day. Patients will take the capsule once in the morning before break
Sponsors
Aragon Institute of Health Sciences (Instituto Aragonés de Ciencias de la Salud) (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients (males and females) with Barrett?s esophagus (>18 years and <80) without macroscopic esophagitis at endoscopy 2. A length of the metaplasic mucosa of 2 cm or longer 3. Who agree to participate in the study
Exclusion criteria
Exclusion criteria: 1. Presence of carcinoma or high grade dysplasia at basal endoscopy 2. Oprevious gastric or esophageal surgery 3. Patients on nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin treatment (a maximum of 5 days per month is allowed. Paracetamol will be used as the standard analgesic treatment) 4. Neoplastic malignancies 5. Hematological serious diseases (coagulation disorders and anemia with Hb < 9.5 gr/dL) 6. Serious/moderate cardiac, liver or renal diseases 7. Need of corticosteroid therapy (a minimum of 5 days per month is allowed, as well as topical or inhaled treatment) 8. Patients on misoprostol or anticoagulants 9. Patients with inflammatory bowel disease and allergy to investigational drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Oxidative stress 1.1. Peroxynitrite production. This variable will be measured by immunohistochemistry (IHQ) with a monoclonal Ab against nitrotyrosine residues in biopsy specimens taken from the metaplastic mucosa of patients with Barrett?s esophagus (four samples every 2 cm) (Chemicon, Temecula, CA, USA). 1.2. DNA oxidative damage: We will determine levels of 8-hydroxy-2?-deoxyguanosine in biopsy specimens form patients with Barrett?s esophagus, as described above. DNA will be extracted with a commercial kit from Qiagen (QIAamp DNA Mini Kit). 8-hydroxy-2?-deoxyguanosina quantification will be carried out by enzyme immunoassay (EIA) (Bioxytech 8-OHdG-EIA kit, OXIS Health Products). Measured at day 0 and final measurement 180 days since the beginning inclusion of patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biological markers of diseases progression 1.1. Cell proliferation (Ag ki67-mib1) measured by automatic morphometry NIH-Image 6.1 1.2. Apoptosis: measured by IHQ with cysteine-dependent aspartate-directed proteases (caspase) 1.3. Molecular markers of neoplastic progression 2. The presence of DNA anomalies (tetraploidy and aneuploidy) will be determined by static cytometry Measured at day 0 and final measurement 180 days since the beginning inclusion of patient. | — |
Countries
Spain
Outcome results
None listed