Veiligheid en effectiviteit van een nieuwe 'big-cup partially covered' stent als palliatieve behandeling van een kwaadaardige maaguitgangsobstructie.
Recruiting
- Conditions
- malignant gastric outlet obstruction, stent placement, enteral stent, cholangiocarcinoma, duodenal cancer, gastric cancer, pancreatic cancer
- Registration Number
- NL-OMON28005
- Lead Sponsor
- Academic Medical Center, University of Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Histological proven malignancy of the periduodenal area;
2. GOOSS-score of 0 (no oral intake), 1 (liquids only) or 2 (soft solids) (see
table 1) and/or suffering from nausea or vomiting or early satiety;
Exclusion Criteria
1. Potentially curable disease;
2. Obstruction of the proximal stomach;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stent patency.
- Secondary Outcome Measures
Name Time Method 1. Technical success defined as successful placement and deployment of the<br>stent across the stricture;<br /><br>2. Clinical success defined as relief of symptoms compatible with GOO and/or<br>an improvement of the GOOSS-score 1 week after stent placement;<br /><br>3. Improvement of the GOOSS-score during total follow-up;<br /><br>4. Procedure (for example perforation, bleeding and sepsis) and stent-related<br>(for example stent migration, stent occlusion by tumor ingrowth, late onset<br>perforation) complications including 30-day mortality;<br /><br>5. Quality of life score (EORTC QLQ-C30 (version 3) combined with EQ-5D including the EQ-VAS);<br /><br>6. WHO performance status;<br /><br>7. Procedure-related hospitalization time (days);<br /><br>8. Time until regain of oral intake (days);<br /><br>9. Survival (days).