Efficacy of a new Wallflex Duodenal Soft stent for palliation of gastric outlet obstructio
Recruiting
- Conditions
- Malignant gastric outlet obstruction
- Registration Number
- NL-OMON24271
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
• Histologically proven malignant gastric outlet obstruction
• Gastric Outlet Obstruction Scoring System (GOOSS) score of =2
• No curative treatment options available
• Planned to undergo duodenal SEMS insertion
• Life expectancy of less than 3 months
• Age = 18 years
• Written informed consent*
*To collect data from the electronic patient system
Exclusion Criteria
• Previous SEMS insertion for the same condition
• Patients with pre-procedural evidence of an additional more distally located stricture (i.e. small bowel or colon)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of the WallFlex Duodenal Soft Stent in palliation of GOO-symptoms
- Secondary Outcome Measures
Name Time Method Safety and overall functional outcomes, including WHO-performance score, days of admission both after stent placement and for (S)AE, quality of life and overall survival