Barrett's esophagus
Conditions
Interventions
Endoscopic resection (ER) of visible lesions and early cancer (EC) followed by radiofrequency ablation (RFA) of the residual Barrett's epithelium.
Sponsors
Academic Medical Center
Dept. of Gastroenterology and Hepatology
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria prior to Endoscopic Resection: 1. Patients in the age of 18-85 years with HGD or EC in a Barrett's esophagus. 2. An endoscopically visible abnormality containing HGD a/o EC and no endoscopic signs suggestive of submucosal invasion. 3. Patients with no visible abnormalities and a pretreatment diagnosis of HGD are also eligible. These patients will not undergo an ER and are directly amendable for RFA treatment. 4. Pretreatment biopsies reviewed by an expert local pathologist. 5. EUS without signs of deep submucosal invasion or suspicious local lymph nodes. 6. Normal CT-scan of thorax and upper 1/3 of the abdomen using 5-mm slices (only for patients with invasive cancer in their pretreatment biopsies or ER specimens). 7. Informed written consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria prior to Endoscopic Resection: 1. Patients with a Barrett's segment >12 centimeters. 2. Any prior endoscopic treatment of Barrett's neoplasia. 3. Any prior endoscopic dilatation for esophageal stenosis. 4. Patients unable to give informed consent. Exclusion criteria based on the outcome of the ER: 1. An endoscopic resection measuring more than 50% of the esophageal circumference or more than 2 cm in longitudinal extent. 2. Patients with endoscopic resection of multiple lesions in a single ER session are not eligible if one of the resections measures more than the aforementioned size criteria, OR if resections of different lesions are not separated by a free circumferential segment of at least 1 cm. 3. Positive vertical resection margins, deep submucosal invasion (T1sm2), poorly or undifferentiated cancer (G3 or G4), or lymphatic/vascular invasion in any of the ER specimens. 4. Remaining visible abnormalities suggestive of possible submucosal ingrowth: type 0-Is, type 0-III or otherwise according to the discretion of the endoscopist. 5. Symptomatic dysphagia or esophageal dilatation after the ER. 6. Invasive cancer in any of the biopsies obtained at high-resolution endoscopy after the ER: biopsies should be reviewed in Amsterdam before patients are excluded based on this criterion. 7. An interval > 3 months between the last high-resolution endoscopy with biopsies and RFA. 8. An interval < 6 weeks between ER and RFA. 9. Patients unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary clinical outcome parameters assessed at t=6 and t=12 months: 1. Rate of total histological eradication of HGD and EC 2. Rate of total endoscopic eradication of Barrett's mucosa 3. Rate of total histological eradication of Barrett's mucosa | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters 1. Acute and late complications of ER and RFA 2. Percentage of surface regression of Barrett's epithelium 3. Number of treatment sessions required to eradicate all Barrett's mucosa | — |
Contacts
Public ContactJ.J.G.H.M. Bergman
Academic Medical Center Bldg. C2-210, Meibergdreef
Outcome results
None listed