Multi-band mucosectomy plus BARRx Radiofrequency Ablation for Eradication of High-Grade Dysplasia and Early Cancer in Barrett's oesophagus.

Multi-band mucosectomy plus BARRx Radiofrequency Ablation for Eradication of High-Grade Dysplasia and Early Cancer in Barrett's oesophagus. - RFA-EURO-I

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30022

Enrollment

Registered

2006-11-17

Start date

2006-10-01

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 heartburn

Interventions

Patients will be treated for their Barrett's esophagus with dysplasia or early cancer. Patients will undergo an endoscopic resection with the MBM technique for a focal lesion followed by RadioFreque

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients in the age of 18-85 years with HGD or EC in a Barrett*s esophagus. 2. An endoscopically visible abnormality containing HGD a/o EC with a circumferential extent

Exclusion criteria

Exclusion criteria: 1. Patients with a Barrett*s segment >12 centimeters. 2. Any prior endoscopic treatment of Barrett*s neoplasia. 3. After the ER but before RFA: positive vertical resection margins in any of the ER specimens. 4. After the ER but before RFA: remaining visible abnormalities containing HGD or EC after ER (additional ER is allowed). 5. After the ER but before RFA: esophageal stenosis due to scarring after the previous ER, defined as resistance in passing a therapeutic gastroscope. 6. After the ER but before RFA: any invasive cancer in biopsies obtained at high-resolution endoscopy after ER but before the RFA treatment. 7. After the ER but before RFA: absence of LGD and HGD in biopsies obtained at high-resolution endoscopy after ER but before the RFA treatment. 8. After the ER but before RFA: an interval > 3 months after the last high-resolution endoscopy with biopsies between ER and RFA. 9. After the ER but before RFA: an interval

Design outcomes

Primary

Measure	Time frame
Primary clinical outcome parameters will be assessed at t=6 and t=12 months: 1. Rate of total histological eradication of HGD and EC 2. Rate of total endoscopic eradication of Barretts mucosa 3. Rate of total histological eradication of Barretts mucosa	—

Secondary

Measure	Time frame
1. Acute and late complications of MBM and RFA 2. Percentage of surface regression of Barrett*s epithelium 3. Number of treatment sessions required	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)