Etude de Cohorte Sur l'Utilisation du Dispositif BOUGIE CAP™ Pour le Traitement Des sténoses œsophagiennes bénignes et Courtes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The primary endpoint is the clinical success of esophageal strictures dilated by BOUGIE CAP™ at 6 months.
Study Overview
Brief Summary
Benign esophageal strictures are a common condition with multiple and varied causes. Esophageal strictures are manifested by the appearance of dysphagia, usually when the reduction in the esophageal lumen is greater than 50%. Malnutrition and aspiration pneumonia can also occur. Quality of life can thus be significantly impaired. To date, there are multiple techniques for treating strictures. Dilation (hydrostatic or bougie) is the historical first-line treatment. The effectiveness of the 2 historical dilation methods (balloon vs bougie) is comparable, with no difference in terms of adverse effects, with robust literature on the subject. There is a new device called the BougieCap™ (Ovesco Endoscopy AG, Tubingen, Germany). It is a short, tapered, conical-shaped transparent cap that attaches to the end of the endoscope. This cap allows the treatment of short strictures, with direct visualization during dilation.
The results of this research will be used to better evaluate the performance of the Bougie Cap™ in the endoscopic dilation of short benign esophageal strictures as well as its short-term effectiveness on dysphagia. Another advantage of this device, particularly compared to older techniques, is its ecological potential (lower packaging weight).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient aged 18 or over
- •Benign esophageal stricture diagnosed by endoscopy and confirmed by histology negative for malignancy
- •Short stenosis
- •With dysphagia
- •With indication for first-line endoscopic treatment
Exclusion Criteria
- •- A patient objects to the collection or processing of their data.
- •The patient did not want his health data to be used after his death.
- •Patient under guardianship, curatorship
- •Pregnant woman
- •Malignant stenosis
- •Congenital stenosis
- •Associated fistula
Outcomes
Primary Outcomes
The primary endpoint is the clinical success of esophageal strictures dilated by BOUGIE CAP™ at 6 months.
Time Frame: Patients managed with monthly BOUGIE CAP™ procedures for esophageal strictures will be evaluated during a 6-month follow-up
Patients managed with monthly BOUGIE CAP™ procedures for esophageal strictures during a 6-month follow-up will be assessed. The success of the endoscopic dilation sequence is defined by the technical ability to achieve dilation to a diameter of at least 14mm
Secondary Outcomes
No secondary outcomes reported