Barrett's esophagus Barrett's neoplasia
Conditions
Interventions
Circumferential ablation of 3cm of length of Barrett*s epithelium using the
CBAS180 at decremental dosages during an upper endoscopy.
Sponsors
Pentax Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Flat type BE esophagus, with an indication for ablation therapy, defined as: a) Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or; b) Residual BE with any grade of dysplasia after endoscopic resection (by means of EMR or ESD) to treat non-flat BE, >=6 weeks prior to enrolling the patient to this study. The ER pathology should indicate endoscopic treatment (i.e. only mucosal invasion or limited submucosal invasion (sm1), no lymphovascular infiltration, free vertical resection margins and not poorly differentiated). 2) Prague Classification Score of C=1. 3) Patients should be ablation-naïve, meaning they have not undergone any previous endoscopic ablation therapy of the esophagus. 4) Older than 18 years of age at time of consent. 5) Fit for endoscopic therapy per institution*s standards. 6) Provides written informed consent on the IRB-approved informed consent form. 7) Willing and able to comply with follow-up requirements.
Exclusion criteria
Exclusion criteria: 1) Esophageal stenosis preventing advancement of a therapeutic endoscope. 2) Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER >=6 weeks prior to planned treatment under this protocol. 3) Prior ER of >2cm in length and/or >50% of the esophageal lumen circumference. 4) History of locally advanced (>sm1) esophageal cancer. 5) History of esophageal varices. 6) Prior distal esophagectomy. 7) Active esophagitis LA grade B or higher. 8) Severe medical comorbidities precluding endoscopy. 9) Uncontrolled coagulopathy. 10) Pregnant or planning to become pregnant during period of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Efficacy defined as the median BE surface regression percentage after 1 circumferential treatment session, as evaluated by the EGD-Adjudication Committee and confirmed by histological evidence of eradication of BE. 2) Safety defined as the incidence of dose-related serious adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Feasibility (technical success) defined as the percentage of patients in whom all BE could be treated as intended by the treating endoscopist. 2) Post-procedure pain in the area of the cryoablation treatment (0-10 NRS), described as the median pain scores directly, 1, 7 and 30 days after treatment. 3) Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia scores directly, 1, 7 and 30 days after treatment. 4) Incidence of all serious and non-serious AEs up to 30 days post-treatment. 5) Median BE surface regression percentage after 1 circumferential treatment session as assessed by the treating endoscopist. | — |
Countries
Netherlands
Outcome results
None listed