No registrations found.
ID
Source
Brief title
Health condition
Benign esophageal stricture
Sponsors and support
Ovesco Endoscopy AG
Intervention
Outcome measures
Primary outcome
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 outcome
- Single EBD procedure time
- Total number of EBD procdures with the BougieCap dilator
- Recurrent dysphagia (Ogilvie 2-4) during follow-up of 12 weeks
Background summary
This multicenter non-randomized prospective observational cohort study will assess the feasibility of BougieCap dilation for patients with benign esophageal strictures. After dilation up to 18 mm, patients are followed up until 3 months and dysphagia scores, recurrent dysphagia and adverse events will be documented.
Study objective
In this study we aim to assess the feasibility in daily clinical practice of endoscopic BougieCap dilation for patients with a benign esophageal stricture.
Study design
Baseline: intervention (dilation up to 18 mm)
4 weeks: telephonic consultation
8 weeks: telephonic consultation
12 weeks: telephonic consultation
Incidental follow-up: BougieCap dilation for recurrent dysphagia
Intervention
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 for dilating/expanding esophageal strictures. The BougieCap is available in different diameters to perform incremental dilation (up to 6 mm) during a single procedure, identical to the conventional Savary bougie dilation. The standard endoscope plus BougieCap acts as a conventional Savary dilator, but with endoscopic view during dilation as the important extra feature.
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7483 |
| NTR-old | NTR7725 |
| Other | : 2018-4530 |