Barrett's esophagus
Conditions
Interventions
Single-arm therapeutic intervention study including 60 patients with Barrett's esophagus with low- or high-grade dysplasia without evident endoscopic lesions or with previous treatment by endoscopic r
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Barrett's esophagus with low-grade dysplasia without evident lesions; Barrett's esophagus with high-grade dysplasia without evident lesions; Barrett's esophagus remaining endoscopic post-treatment of visible low- and high-grade dysplastic lesions of dysplasia and / or intramucosal adenocarcinoma.
Exclusion criteria
Exclusion criteria: Having a severe systemic disease or psychiatric disorder; Having a pacemaker; Biopsies showing no BE-related intestinal metaplasia;Barrett's esophagus with areas showing no current or previous dysplasia; refusal to sign the free and informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome include the complete eradication of dysplasia in the Barrett's esophagus after treatment with radiofrequency, confirmed by endoscopy and biopsies performed after the intervention. ;Primary outcome include the complete eradication of intestinal metaplasia in the Barrett's esophagus after treatment with radiofrequency, confirmed by endoscopy and biopsies performed after the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the rate of recurrence of dysplasia confirmed by any degree of dysplasia found in biopsies after radiofrequency treatment;Evaluate complications resulting from the procedure, including pain, fever, perforation, mucosal lacerations, stenosis, significant bleeding (with hemodynamic repercussion and / or need for blood transfusion);Evaluate if there are differences in the rates of recurrence of intestinal metaplasia in patients with and without fundoplication. The fundoplication is expected to protect against recurrence of intestinal metaplasia and dysplasia. | — |
Countries
Brazil
Contacts
Public ContactSergio Marques
Universidade de São Paulo
Outcome results
None listed