Efficacy and safety of focal cryoballoon ablation for patients with dysplastic Barrett's esophagus
Recruiting
- Conditions
- Barrett's esophagusBarrett slokdarm
- Registration Number
- NL-OMON25207
- Lead Sponsor
- St. Antonius Hospital, Nieuwegein
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 107
Inclusion Criteria
Indicated for ablation therapy of Barrett’s epithelium, determined by:
o Histopathologically-confirmed LGD or HGD in flat-type BE with four quadrant biopsies of every 2cm of the BE segment in the last 6 months, or
Exclusion Criteria
- Esophageal stenosis preventing advancement of a therapeutic endoscope
- Prior endoscopic resection (EMR or ESD) >2cm in length AND/OR >50% of the esophageal circumference
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy, defined as:<br /><br>- CE-IM; the percentage of patients with complete eradication of all Barrett’s epithelium on endoscopy AND CE-IM in all biopsies obtained at the first follow-up endoscopy after the maximum of 5 treatment sessions (and escape treatment(s) if necessary).<br /><br>- CE-D; the percentage of patients with CE-D in all biopsies obtained at the first follow-up endoscopy after the maximum of 5 treatment sessions (and escape treatment(s) if necessary).
- Secondary Outcome Measures
Name Time Method