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Long-term follow-up after RFA with or without prior EMR for early Barrett's neoplasia

Long-term follow-up after RFA with or without prior EMR for early Barrett's neoplasia - 5-year FU after RFA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36820
Enrollment
55
Registered
2011-10-26
Start date
2011-06-10
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

(early) esophageal cancer Barrett's esophagus

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - All eligible patients treated with RFA in the AMC-I/AMC-II/AMC-IV/EURO-I study (resp. MEC05/082 and MEC06/011, MEC 06/184, MEC 06/189), who are now being followed-up endoscopically in the AMC or referral centre in the Netherlands - Written informed consent

Exclusion criteria

Exclusion criteria: - No justification for further follow-up due to (unrelated) comorbidity

Design outcomes

Primary

MeasureTime frame
- Rate of complete histological remission of dysplasia and cancer - Rate of complete endoscopic and histological eradication of IM (including biopsies obtained from neosquamous mucosa)

Secondary

MeasureTime frame
- Prevalence of subsquamous IM in neosquamous biopsies and ER-specimens - Prevalence of IM below the Neo Z-line during 5-year follow-up visits - Adverse events

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)