Barrett's esophagus with biopsy-proven low-grade dysplasia, high-grade dysplasia or early cancer Digestive System Barrett oesophagus
Conditions
Interventions
In all 30 patients that will be included in this study, the Barrett’s segment will be circumferentially treated using the 360 Express RFA balloon catheter.
RFA treatment
Study Device
Circumferentia
Sponsors
GI solutions, a subsidiary of Covidien, Inc. (Formerly BARRX Medical, Inc.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 85 years 2. BE segment between 2 and 10 cm at baseline, prior to any ER 3. Biopsy proven LGD, HGD or cancer confirmed by an expert pathologist 4. in case of prior ER for early cancer or visible lesions, the resection had to be limited to <2 cm in length and <50 % of the circumference 5 Written informed consent
Exclusion criteria
Exclusion criteria: 1. Prior endoscopic ablation treatment 2. Significant esophageal stenosis preventing passage of a diagnostic endoscope or any prior endoscopic dilatation for esophageal stenosis 3. In case of prior ER: positive vertical resection margins, deep submucosal invasion (>T1sm1), poorly or undifferentiated cancer (G3-G4), or lymphatic/vascular invasion 4. In case of prior ER: no invasive cancer in any of the biopsies obtained from residual BE 5. An interval of > 6 months between the last high-resolution endoscopy with biopsies and the RFA treatment, or an interval < 6 weeks between ER and RFA 6. Contra-indications for RFA treatment (e.g. anti-coagulant therapy (apart from aspirin or NSAID) that could not be discontinued prior to RFA, esophageal varices)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of endoscopically visual surface regression of BE epithelium at 3 months. The percentage of endoscopically visible surface regression of BE will be independently scored by two endoscopists who reviewed the endoscopic images that were taken from every cm of the original BE segment immediately prior to the initial circumferential RFA procedure and during the first post-treatment endoscopy at 3 months. The primary outcome is defined as the mean percentage of BE surface regression of the two endoscopists. In case the BE surface regression percentage differs =30% between both endoscopists, a new score will be established during a consensus meeting. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of the 360 Express ablation procedure. The total procedure duration is defined as the time from the first introduction of the endoscope until the time of removal of the endoscope. The ablation time is defined as the period between the introduction of the 360 Express catheter and the removal of the 360 Express catheter. 2. Adverse events related to the 360 Express ablation procedure. Timing of complications is defined as ‘acute’ (during the procedure), ‘early’ (=48 hours), or ‘late’ (>48 hours). Severity of complications is graded as ‘mild’ (unscheduled hospital admission, hospitalization 10 days, intensive care unit admission, need for surgery, >4 units blood transfusion; or in the case of stenosis >5 dilations, stent placement, or incision therapy), or ‘fatal’ (death attributable to procedure <30 days or longer with continuous hospitalization) 3. Rate of complete endoscopic and histological eradication of dysplasia (CE-D) and intestinal metaplasia (CE-IM) at the end of the treatment phase 4. Number of patients with a stenosis requiring dilation at any time during the treatment phase | — |
Countries
Netherlands
Contacts
Public ContactKamar Belghazi
Outcome results
None listed