5 year follow-up after treatment with radiofrequency ablation for Barrett's esophagus containing HGIN or early cancer.
- Conditions
- Barrett's esophagus / Barrett slokdarmBarrett's cancer / Barrett kankerBarrett's neoplasiaBarrett's dysplasia Radiofrequency ablation
- Registration Number
- NL-OMON27049
- Lead Sponsor
- Academic Medical Centre Amsterdam, Department of Gastroenterology and Hepatology
- Brief Summary
1. Gondrie JJ, Pouw RE, Sondermeijer CM, Peters FP, Curvers WL, Rosmolen WD, Ten KF, Fockens P, Bergman JJ. Effective treatment of early Barrett's neoplasia with stepwise circumferential and focal ablation using the HALO system. Endoscopy 2008;40:370-379;<br> 2. Gondrie JJ, Pouw RE, Sondermeijer CM, Peters FP, Curvers WL, Rosmolen WD, Krishnadath KK, Ten KF, Fockens P, Bergman JJ. Stepwise circumferential and focal ablation of Barrett's esophagus with high-grade dysplasia: results of the first prospective series of 11 patients. Endoscopy 2008;40:359-369. 3.Phoa KN, Pouw RE, van Vilsteren FG, Sondermeijer CM, Ten Kate FJ, Visser M, Meijer SL, van Berge Henegouwen MI, Weusten BL, Schoon EJ, Mallant-Hent RC, Bergman JJ. Gastroenterology. 2013 Mar 28. pii: S0016-5085(13)00460-5 (Epub ahead of print)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
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.
No justification for further follow-up due to (unrelated) comorbidity, or otherwise.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Rate of complete histological remission of dysplasia and cancer at 5-yr follow-up;<br /><br>2. Rate of complete endoscopic and histological eradication of IM (including biopsies obtained from neosquamous mucosa) at 5-year follow-up.
- Secondary Outcome Measures
Name Time Method 1. Prevalence of subsquamous IM in neosquamous biopsies and ER-specimens;<br /><br>2. Prevalence of IM below the Neo Z-line during 5-year follow-up visits;<br /><br>3. Adverse events.