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A Randomised Trial comparing Surveillance with Radio-Frequency Ablation of Barrett*s Esophagus with Low-Grade Dysplasia; the SURF-study

A Randomised Trial comparing Surveillance with Radio-Frequency Ablation of Barrett*s Esophagus with Low-Grade Dysplasia; the SURF-study - Radiofrequency ablation vs surveillance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35588
Enrollment
120
Registered
2006-10-13
Start date
2007-06-18
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's esophagus precancerious condition

Interventions

Patients, who are randomized for radiofrequency ablation will be treated for low-grade dysplasia in Barrett's esophagus with radiofrequency ablation.

Sponsors

BARRx Medical Inc
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Low-grade dysplasia in Barrett's slokdarm

Exclusion criteria

Exclusion criteria: Patients with a Barrett's segment of >12cm

Design outcomes

Primary

MeasureTime frame
Rate of high-grade dysplasia and early cancer during two year follow-up

Secondary

MeasureTime frame
1. Rate of total histological eradication of LGD 2. Rate of total endoscopic eradication of Barrett*s mucosa 3. Rate of total histological eradication of Barrett*s mucosa 4. Number of procedures and costs 5. Acute and late complications of RFA 6. Percentage of surface regression of Barrett*s epithelium

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)