Multicenter European prospective study on the efficacy and safety of the Focal C2 CryoBalloon Ablation System in patients with Barrett*s Esophagus-related neoplasia

Recruiting

• Conditions: Barrett's esophagus; Barrett's neoplasia; 10017990; 10017991

• Registration Number: NL-OMON50590
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

1. 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
o Residual flat BE (with or without dysplasia) after endoscopic resection of a
focal lesion (by means of EMR or ESD) of non-flat BE, at least 6 weeks prior to
enrolling the patient to this study. The histopathologic evaluation of the
resected specimen should indicate endoscopic treatment (i.e., no more than only
superficial submucosal invasion (<=T1sm1/<500 microns), absence of
lymphovascular invasion, not poorly differentiated, free deep (vertical)
resection margins).
NB: In case of performed endoscopic resection, the absence of residual cancer
in the remaining Barrett*s epithelium should be confirmed with random biopsies
(these biopsies might be taken during the same endoscopy, but a maximum
interval of 6 months is allowed between these biopsies).
2. Ablation naïve (no previous ablation therapy of the esophagus)
3. Prague Classification <=C2 / <=M5 (including BE tongues, excluding small BE
islands, in case of endoscopic resection the Prague Classification AFTER
endoscopic resection)
4. Older than 18 years of age at time of consent
5. Operable per institution*s standards
6. Informed consent

Exclusion Criteria

1. Esophageal stenosis preventing advancement of a therapeutic endoscope
2. Prior endoscopic resection (EMR or ESD) >2cm in length AND/OR >50% of the
esophageal circumference
3. Prior distal oesophagectomy
4. Active oesophagitis grade B or higher (patients can be included after
appropriate treatment of reflux oesophagitis)
5. History of oesophageal varices
6. Achalasia
7. Severe medical comorbidities precluding endoscopy
8. Uncontrolled coagulopathy
9. Pregnant or planning to become pregnant during period of study participation
10. Life expectancy <=2 years, as judged by the site investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is efficacy, defined as:<br /><br>- Complete eradication of intestinal metaplasia (CE-IM): the percentage of<br /><br>patients with complete eradication of all Barrett*s epithelium on endoscopy AND<br /><br>CE-IM in all biopsies obtained at the first follow-up endoscopy after the<br /><br>maximum of 5 treatment sessions (and escape treatments if necessary).<br /><br>- Complete eradication of dysplasia (CE-D): the percentage of patients with<br /><br>CE-D in all biopsies obtained at the first follow-up endoscopy after the<br /><br>maximum of 5 treatment sessions (and escape treatment if necessary). </p><br>