No registrations found.
ID
Source
Brief title
Health condition
Barrett esophagus; high-grade dysplasia; high-grade intraepithelial neoplasia; intramucosal cancer; Barrett neoplasia; intestinal metaplasia.
Barrett slokdarm; hooggradige dysplasie; hoogradige intraepitheliale neoplasie; Barrett neoplasie; intestinale metaplasie.
Sponsors and support
540 Oakmead Parkway
Sunnyvale, CA 94085
540 Oakmead Parkway
Sunnyvale, CA 94085
Intervention
Outcome measures
Primary outcome
1. Rate of total histological eradication of HGD and/or EC
2. Rate of total endoscopic eradication of Barrett's mucosa
3. Rate of total histological eradication of Barrett's mucosa
Secondary outcome
1. Acute and late complications of RER/RFA
2. Percentage of surface regression of Barrett's epithelium
3. Costs of materials and procedures
Background summary
We will perform a randomized trail comparing RER and RFA for the treatment of patients with Barrett's esophagus <5 cm containing high-grade dysplasia or early cancer, to investigate which treatment regimen is superior in terms of efficacy, early complication rate, late complication rate and the presence of buried Barrett's.
Study design
- T= 0: inclusion: first RER/RFA.
- T= 6 weeks: second RER/RFA.
- T=12 weeks: third RER/RFA.
- T=18 weeks: final RER/RFA.
- T=24 weeks: assessment of primary outcome parameters by endoscopy with lugol staining and biopsies.
Follow-up
- First year: every 6 months: endoscopy with lugol staining and biopsies below neo-squamocolumnar junction, residual Barrett's mucosa and neosquamous epithelium.
- From second year: annual endoscopy with lugol staining and biopsies below neo-squamocolumnar junction, residual Barrett's mucosa and neosquamous epithelium.
Intervention
Stepwise radical endoscopic resection (RER), or radiofrequency ablation (RFA)
Bldg. C2-210, Meibergdreef
J.J.G.H.M. Bergman
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
j.j.bergman@amc.uva.nl
Bldg. C2-210, Meibergdreef
J.J.G.H.M. Bergman
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
j.j.bergman@amc.uva.nl
Inclusion criteria
1. Patients with biopsy proven HGD or EC in a Barrett's esophagus in at least 2 endoscopic procedures prior to randomization, of which the last was within 3 months of randomization.
2. Age between 18 and 85 years.
3. Type I, IIa, IIb or IIc lesions
4. Maximum size of visible lesions: length < 3 cm, circumferential extend <50%.
5. No signs of deep submucosal infiltration on endoscopic inspection and EUS.
6. No signs of metastatic disease on endoscopic ultrasound (EUS) or CT-scan of thorax and abdomen (CT is only required for those with cancer in biopsies or EMR specimens).
7. Informed written consent.
Exclusion criteria
1. Length of Barrett's esophagus > 5 cms.
2. Deep submucosal infiltration („dT1sm2) in the endoscopic resection specimen.
3. Significant stenosis (not allowing passage of a therapeutic endoscope) after the initial EMR and prior to RFA.
4. Presence of invasive cancer in biopsies prior to RFA.
5. Patients unable to give informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1290 |
| NTR-old | NTR1337 |
| Other | : B-206 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |