5 year follow-up after treatment with radiofrequency ablation for Barrett's esophagus containing HGIN or early cancer.

Radiofrequency Ablation with or without Endoscopic Resection for Barrett’s Esophagus containing High-Grade Intraepithelial Neoplasia and/or Early Cancer: Durability of the Post-Treatment Neosquamous Epithelium at 5-year Follow-up.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27049

Enrollment

Registered

2011-06-14

Start date

2011-04-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Barrett's esophagus / Barrett slokdarm Barrett's cancer / Barrett kanker Barrett's neoplasia Barrett's dysplasia Radiofrequency ablation

Interventions

1. Endoscopic surveillance with biopsies according to the Seattle protocol

2. EUS

3. Endoscopic resection of the neosquamous epithelium.

Eligibility

Inclusion criteria

Inclusion criteria: 1. All eligible patients treated with RFA (AMC-I/II, AMC-IV and EURO-I), according to the aforementioned study protocols, who are now being followed-up endoscopically in the AMC or referral centre within the Netherlands; 2. Written informed consent.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Rate of complete histological remission of dysplasia and cancer at 5-yr follow-up; 2. Rate of complete endoscopic and histological eradication of IM (including biopsies obtained from neosquamous mucosa) at 5-year follow-up.	—

Secondary

Measure	Time frame
1. Prevalence of subsquamous IM in neosquamous biopsies and ER-specimens; 2. Prevalence of IM below the Neo Z-line during 5-year follow-up visits; 3. Adverse events.	—

Contacts

Public ContactJ.J.G.H.M. Bergman

Academic Medical Center Bldg. C2-210, Meibergdreef

j.j.bergman@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)