In this study we aim to assess the feasibility in daily clinical practice of endoscopic BougieCap dilation for patients with a benign esophageal stricture.
ID
Bron
Verkorte titel
Aandoening
Benign esophageal stricture
Ondersteuning
Ovesco Endoscopy AG
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main endpoint is the feasibility of EBD with the BougieCap dilator in patients with benign esopahgeal strictures. Feasibility is defined as:<br>
- technical success of repeated EBD to 18mm with the BougieCap dilator according to standard practice for EBD
Achtergrond van het onderzoek
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.
Doel van het onderzoek
In this study we aim to assess the feasibility in daily clinical practice of endoscopic BougieCap dilation for patients with a benign esophageal stricture.
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7483 |
| NTR-old | NTR7725 |
| Ander register | : 2018-4530 |