Benign esophageal stricture
Conditions
Interventions
Endoscopic dilation with the BougieCap dilator. In sequential dilation procedure the benign stricture will be dilated up to 18 mm.
BougieCap dilator: an endoscopic attachment cap intended to be used
Sponsors
Radboud university medical center
Eligibility
Inclusion criteria
Inclusion criteria: - Patients presenting with first episode of dysphagia due to benign esophageal stricture requiring repeated EBD to 18 mm - Dysphagia due to benign esophageal stricture (e.g. post-surgery, radiation therapy, caustic ingestion, peptic, post-endotherapy) - Dysphagia for solid, semisolid or liquid food (Ogilvie dysphagia score: 2-4) - Written informed consent
Exclusion criteria
Exclusion criteria: - Patient with a known eosinophilic esophagitis or motility disorder (e.g. achalasia) - Patients with a known or suspected malignant esophageal stricture - Patients with a benign stricture due to a previously performed laryngectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is the feasibility of EBD with the BougieCap dilator in patients with benign esopahgeal strictures. Feasibility is defined as: - technical success of repeated EBD to 18mm with the BougieCap dilator according to standard practice for EBD | — |
Secondary
| Measure | Time frame |
|---|---|
| - Single EBD procedure time - Total number of EBD procdures with the BougieCap dilator - Recurrent dysphagia (Ogilvie 2-4) during follow-up of 12 weeks | — |
Outcome results
None listed