randomized, multicenter study
Conditions
Interventions
1. Duodenal stent placement
Sponsors
ZonMW
Eligibility
Inclusion criteria
Inclusion criteria: 1. Obstructive cancer (more than 25% of the circumference as seen by endoscopy) extending from the distal duodenum; 2. Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only); 3. Incurable or metastatic disease; 4. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Evidence of other strictures in the gastrointestinal (GI) tract; 2. Previous gastric, periampullary or duodenal surgery; 3. Previous (palliative) treatment for the same condition; 4. WHO performance score of 4 (patient is 100% of time in bed); 5. Unable to fill out quality of life questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total area under the survival curve, adjusted for the abillity to eat at least soft solids (GOOSS score of 2 or more). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Procedure-related (within 7 days) and long term (later than 7 days) minor and major complications; 2. Reinterventions or recurrent obstructions; 3. Survival, calculated from day of randomization; 4. Health related quality of life, including the perceived burden of the procedure, burden of reintervention and generic and disease specific HRQoL; 5. Cost and cost-effectiveness. | — |
Contacts
Public ContactS.M. Jeurnink
Erasmus Medical Center, Department of Gastroenterology and Hepatology, room HS 510, P.O. Box 2040
Outcome results
None listed