Esophageal stent BD-Covered for refractory benign esophageal strictures: a safety and efficacy study

Phase 2

Withdrawn

Conditions: esophageal narrowing
esophageal refractory benign stricture
10018008

Registration Number: NL-OMON45632

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

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

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The study has two primary outcome measurements<br /><br><br /><br>(i) The efficacy of the device measured by the technical succes of the<br /><br>implantation, i.e. to correct positioning of the stent at the stenosis<br /><br>immediately after the implantation and stent expansion<br /><br>(ii) Safety of using the medical device, measured by registration of<br /><br>complications - migration, pain, food impaction inside the stent, bleeding from<br /><br>implantation site, esophageal perforation etc.).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The study has two secondary objectives:<br /><br><br /><br>1. Long-term efficacy (dysphagia) will be measured at baseline and during<br /><br>follow-up at 3 and 6 months with the Ogilvie dysphagia score.<br /><br>2. Pain during follow-up: the first two weeks pain will be measured daily with<br /><br>a patient diary, using the Visual Analogue Scale (VAS). After this pain will be<br /><br>assessed, using the VAS, during regular controls according to standard care.<br /><br>3. Bodyweight will be measured at baseline and during follow-up of six months<br /><br>at regular controls according to standard care.<br /><br>4. The quality of life of the patients will be evaluated by questionnaire<br /><br>(SF-36) during follow-up of six months at regular controls according to<br /><br>standard care.<br /><br>5. The presence of hyperplastic reaction will be objectified during regular<br /><br>endoscopic controls at three and six months follow-up.</p><br>