Endoscopic BougieCap dilation for benign esophageal strictures: a feasibility study in daily practice
Recruiting
- Conditions
- Benign esophageal stricture
- Registration Number
- NL-OMON27219
- Lead Sponsor
- Radboud university medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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)
Exclusion Criteria
- Patient with a known eosinophilic esophagitis or motility disorder (e.g. achalasia)
- Patients with a known or suspected malignant esophageal stricture
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main endpoint is the feasibility of EBD with the BougieCap dilator in patients with benign esopahgeal strictures. Feasibility is defined as:<br /><br>- technical success of repeated EBD to 18mm with the BougieCap dilator according to standard practice for EBD
- Secondary Outcome Measures
Name Time Method - Single EBD procedure time<br /><br>- Total number of EBD procdures with the BougieCap dilator<br /><br>- Recurrent dysphagia (Ogilvie 2-4) during follow-up of 12 weeks