Overview
Collagenase Clostridium Histolyticum for Refractory Iatrogenic Esophageal Strictures
Status:
Unknown status
Unknown status
Trial end date:
2020-12-30
2020-12-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
In this open-label pilot study we want to investigate whether intralaesional injection with collagenase clostridium histolyticum (XiapexR) into the esophageal stricture followed by dilation 24 hours later improves the outcome of patients with refractory esophageal anastomotic strictures as compared to dilation alone (standard of care).Phase:
Early Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University Hospital, Ghent
Criteria
Inclusion Criteria:The patient is 18-90 years old The patient suffers from dysphagia caused by an iatrogenic
esophageal stricture The stricture is amenable for endoscopic dilation The patient has
undergone at least 1 previous endoscopic dilation for the same stricture The patient has
signed the ICF
Exclusion Criteria:
The patient is not fluent in Dutch