Barrett's esophagus early cancer
Conditions
Interventions
Resection of visible lesion with high grade dysplasia and/or early cancer and
total eradication of Barrett's esophagus.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18-85 years; - Minimum circumferential extent of Barrett's of 2cm prior to treatment - Endoscopic visible abnormality of type 0-I,0-IIa, 0-IIc or a combination therof. - Biopsy proven High grade dysplasia (HGD) or Early cancer (EC) on two seperate endoscopic sampling procedures. - Written informed consent
Exclusion criteria
Exclusion criteria: 1. Barrett's extent of >12cm 2. Any prior endoscopic treatment for esophageal adenocarcinoma of BE associated neoplasia. 3. Signs of local or distant metastasis on EUS (EUS is obligatory). 4. Signs of distant metastasis on CT-scan of thorax and/or abdomen (optional for mucosal lesions). 5. Any of the following findings in any of the ER specimens: G3 or G4 tumor differentiation; lymphatic invasion; infiltration into the submucosa >500µm, a positive deeper resection margin. 6. Endoscopic signs of esophageal varices. 7. Esophageal stenosis not allowing passage of a therapeutic endoscope with an ER-cap. 8. Prior esophageal surgery (except fundoplication). 9. Use of any anticoagulant therapy that can not be discontinued between one week before and 1 week after every treatment session.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The rate of complete remission of HGD and EC in all biopsies obtained at 12 months follow-up. 2. The rate of complete remission of BE, defined as the endoscopic absence of columnar lined epithelium upon inspection with NBI and the absence of intestinal metaplasia in all biopsy specimens obtained at 12 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. The rate of acute (i.e. | — |
Countries
Netherlands
Outcome results
None listed