Benign Esophageal Stricture
Conditions
Brief summary
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae
Detailed description
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae. The follow-up will be 6 months form implantation. After 3 months a control endoscopy will take place to evaluate stent and degradation process.
Interventions
DEVICEBD-Covered esophageal stent
a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures
Sponsors
ELLA-CS , sro
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects of both genders * Age ≥ 18 years * Appropriate cultural level and understanding of the study * Willingness to participate voluntarily in the study and give written informed consent * Refractory benign esophageal stricture with or without fistulae, i.e. the patient has to pass a minimum of 2 and a maximum of 10 failed esophageal dilations to the minimal diameter of 15-mm, using a pneumatic balloon dilator or Savary bougie, not complicated by or malignancy. * Ability to undergo periodic endoscopic follow-up.
Exclusion criteria
* Pregnancy or breastfeeding * Simultaneous participation in another clinical study * Life expectancy of less than 12 months * Malignant esophageal stricture * Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter * Undergone an esophageal stent implantation before.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment associated adverse events during follow-up (safety) | 6 months | Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux. |
| BD-Covered stent placement (feasibility): (1) ease of deployment at intended esophageal location and, (2) incidence of device related adverse events at moment of stent placement | 1 day | Technical success is defined as ease of deployment and placement of the BD-Covered stent at the required esophageal location. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal pain, measured with VAS during follow-up after stent placement | 6 months | Pain will be measured with the VAS during follow-up |
| Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up | 6 months | Recurrent dysphagia during follow-up |
Contacts
Primary ContactBram Vermeulen, Drs.
Backup ContactPeter SiersemA, Dr.
Outcome results
None listed