A randomized trial comparing radiofrequency ablation with step-wise radical endoscopic resection for treatment of Barrett*s esophagus with high-grade dysplasia or early cancer.

A randomized trial comparing radiofrequency ablation with step-wise radical endoscopic resection for treatment of Barrett*s esophagus with high-grade dysplasia or early cancer. - Radiofrequency ablation vs SRER-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30042

Enrollment

Registered

2006-10-30

Start date

2006-08-01

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 oesophagus precancerous condition of the esophagus

Interventions

In RFA, the Barrett*s segment is ablated by radiofrequency ablation through a specially designed balloon (HALO360) which contains a spindle shaped electrode on its outer surface. Balloons with diffe

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients in the age of 18-85 years with HGD/EC in a Barrett*s esophagus. - Pretreatment biopsies and ER specimen reviewed by the study pathologist (Prof. D. F. ten Kate). - In case pretreatment diagnosis is made on biopsy material: biopsies should be obtained at two separate occasions of which the most recent occasion is less than six months prior to inclusion in the study. - In case of previous endoscopic en-bloc resection of focal lesions: the ER specimen should have negative deeper resection margins and no invasive cancer at the lateral margins. - In case of previous endoscopic piece meal resection of focal lesions: all ER specimens should have negative deeper resection margins and the patient should have had two separate endoscopies showing no residual invasive cancer in the remaining Barrett*s mucosa. - Normal EUS - Informed written consent.

Exclusion criteria

Exclusion criteria: - Patients with a Barrett*s segment >5 centimeters. - Any endoscopic visual abnormality detected by high-resolution endoscopy at the RFA procedure. - Invasive cancer in any of the biopsies obtained at two different mapping endoscopies after ER but before RFA. - Any prior endoscopic treatment of Barrett*s neoplasia other than ER. - Patients unable to give informed consent.

Design outcomes

Primary

Measure	Time frame
- total histological eradication of HGD and/or EC. - total endoscopic eradication of Barretts mucosa. - total histological eradication of Barretts mucosa.	—

Secondary

Measure	Time frame
- acute and late complications of RFA - Percentage regression of Barrett's mucosa on the surface. - Changes in 24 hour impedantie-measurments and micro-manometry.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)