esophageal narrowing esophageal refractory benign stricture
Conditions
Interventions
Implantation of the BD-Covered esophageal self expanding stent via an
endoscopic procedure
benign
stricture
trial
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Age * 18 years * 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 be treated with a minimum of 2 and no maximum of esophageal dilation sessions to the minimal diameter of 15-mm, using a balloon dilator or Savary bougie. * Ability to undergo periodic endoscopic follow-up
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study has two primary outcome measurements (i) The efficacy of the device measured by the technical succes of the implantation, i.e. to correct positioning of the stent at the stenosis immediately after the implantation and stent expansion (ii) Safety of using the medical device, measured by registration of complications - migration, pain, food impaction inside the stent, bleeding from implantation site, esophageal perforation etc.). | — |
Secondary
| Measure | Time frame |
|---|---|
| The study has two secondary objectives: 1. Long-term efficacy (dysphagia) will be measured at baseline and during follow-up at 3 and 6 months with the Ogilvie dysphagia score. 2. Pain during follow-up: the first two weeks pain will be measured daily with a patient diary, using the Visual Analogue Scale (VAS). After this pain will be assessed, using the VAS, during regular controls according to standard care. 3. Bodyweight will be measured at baseline and during follow-up of six months at regular controls according to standard care. 4. The quality of life of the patients will be evaluated by questionnaire (SF-36) during follow-up of six months at regular controls according to standard care. 5. The presence of hyperplastic reaction will be objectified during regular endoscopic controls at three and six months follow-up. | — |
Countries
The Netherlands
Outcome results
None listed