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

Conditions: Barrett's oesophagus
heartburn
10017990

Registration Number: NL-OMON30022

Lead Sponsor: BARRx Medical Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

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 <50%, a linear extent of <2 cms, and no endoscopic signs suggestive of submucosal invasion.
3. Pretreatment biopsies reviewed by an expert local pathologist.
4. EUS without signs of deep submucosal invasion or suspicious local lymph nodes.
5. Normal CT-scan of thorax and abdomen using 5-mm slices (optional for patients with only HGD in their pretreatment biopsies and in their ER specimens).
6. Presence of LGD or HGD in the residual Barrett*s segment after ER of the aforementioned endoscopically visible abnormality.
7. Informed written consent.

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 < 6 weeks after the ER.
10. Patients unable to give informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary clinical outcome parameters will be assessed at t=6 and t=12 months:<br /><br>1. Rate of total histological eradication of HGD and EC<br /><br>2. Rate of total endoscopic eradication of Barretts mucosa<br /><br>3. Rate of total histological eradication of Barretts mucosa</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Acute and late complications of MBM and RFA<br /><br>2. Percentage of surface regression of Barrett*s epithelium<br /><br>3. Number of treatment sessions required</p><br>