Barrett's esophagus Barrett slokdarm
Conditions
Interventions
CryoBalloon™ Focal Ablation System (CbFAS)
Sponsors
St. Antonius Hospital, Nieuwegein
Eligibility
Inclusion criteria
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 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 and study inclusion). - Ablation naïve (no previous ablation therapy of the esophagus) - Prague Classification ≤C2 / ≤M5 (including BE tongues, excluding small BE islands, in case of endoscopic resection Prague Classification AFTER endoscopic resection) - Older than 18 years of age at time of consent - Operable per institution’s standards - Informed consent
Exclusion criteria
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 - Prior distal oesophagectomy - Active oesophagitis grade B or higher (patients can be included after appropriate treatment of reflux oesophagitis) - History of oesophageal varices - Achalasia - Severe medical comorbidities precluding endoscopy - Uncontrolled coagulopathy - Pregnant or planning to become pregnant during period of study participation - Life expectancy ≤2 years, as judged by the site investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy, defined as: - 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). - 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
| Measure | Time frame |
|---|---|
| o Safety: Incidence of FCBAS related serious adverse events o CE-IM stratified by baseline stratum (treatment naïve, post-endoscopic resection) and baseline dysplasia grade (LGD, HGD, EAC). o CE-D stratified by baseline stratum (treatment naïve, post-endoscopic resection) and baseline dysplasia grade (LGD, HGD, EAC). o Number of CBA treatments required to achieve CE-IM and/or CE-D. o Percentage of patients requiring escape treatment (EMR, APC) during study participation in order to achieve CE-IM and/or CE-D. o Percentage of patients with progression to LGD, HGD or cancer at first follow-up endoscopy. o Incidence of all (non-treatment related) serious adverse events o Incidence of treatment-related adverse events o Post-procedural pain in the area of CBA treatment scored on a 0-10 point numeric rating scale (NRS) for pain o Post-procedural dysphagia on a validated scale from 0-4 o Usage of analgesics after treatment o Technical success, defined as the percentage of treatment sessions considered complete, which is defined as treatment of all visible BE and the EGJ circumferentially. o The percentage of treatment sessions with device malfunctions (device malfunction is defined as problems with the device or a part of the device that require (partially) device replacement. | — |
Contacts
Public ContactAnouk Overwater
St. Antonius Hospital and University Medical Center Utrecht
Outcome results
None listed