ComVi and D-type Stent in Malignant GOO
Not Applicable
Completed
- Conditions
- Gastric Outlet Obstruction
- Registration Number
- NCT01839292
- Lead Sponsor
- Ajou University School of Medicine
- Brief Summary
Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a common complication of uncovered SEMSs. However, they have revealed a high incidence of stent migration in patients with unresectable malignant gastric outlet obstruction (GOO). A conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth. The aims of this study were to evaluate the clinical outcomes of newly designed conformable covered and uncovered SEMS for palliation of malignant GOO.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
Inclusion Criteria
- adults 18 years of age or older
- obstructive symptoms due to unresectable malignant GOO
- a Karnofsky performance score of more than 30 (13)
Exclusion Criteria
- history of a previous SEMS insertion
- the presence of obstruction in the gastrointestinal tract excluding the gastric outlet
- severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders
- a life expectancy of less than 1 month after SEMS insertion
- history of gastric surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method the stent patency time from stent insertion to restenosis due to stent malfunction or death Up to 1 years
- Secondary Outcome Measures
Name Time Method stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate up to 1 years
Trial Locations
- Locations (1)
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Ajou University Hospital🇰🇷Suwon, Korea, Republic of