No registrations found.
ID
Source
Brief title
Health condition
randomized, multicenter study
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total area under the survival curve, adjusted for the abillity to eat at least soft solids (GOOSS score of 2 or more).
Secondary outcome
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.
Background summary
Objective:
To compare a surgical procedure(gastrojejunostomy, GJJ) with endoscopical stent placement in patients with malignant gastric outlet obstruction (GOO).
Design:
Randomized, multicenter study.
Study population:
Patients with inoperable distal stomach, periampullary or duodenal carcinoma.
Intervention:
GJJ (laparoscopic or open) or duodenal stent placement.
Outcome measures:
1) Medical effects (ability to eat, complications, reinterventions,
survival), 2) Quality of life, and 3) Costs and Cost-effectiveness.
Power:
The sample size calculation is based on total time that patients are not able to eat at least a soft diet after both procedures. For this, a log transformation was performed. Assuming that stent patients are approximately 7 days earlier able to eat a soft diet after treatment, but develop more recurrent obstruction, 2x70 patients are needed for a 84% power at the 5% level (t-test). We will include 2x74 patients to compensate 5% lost to follow-up.
Analysis:
Chi-square test, t-test, Kaplan-Meier method/log rank test and non-parametric analyses with bootstrap techniques.
Economic evaluation:
GJJ and stent placement will be compared in a cost-effectiveness analysis from a societal perspective, including hospital care, health care after discharge, and informal care.
Study objective
To compare a surgical procedure (gastrojejunostomy, GJJ) with endoscopical stent placement in patients with malignant gastric outlet obstruction (GOO)
Intervention
1. Duodenal stent placement;
2. Gastrojejunostomy.
P.O. Box 2040
S.M. Jeurnink
Rotterdam 3000 CA
The Netherlands
+31 (0)6 54954623
s.jeurnink@erasmusmc.nl
P.O. Box 2040
S.M. Jeurnink
Rotterdam 3000 CA
The Netherlands
+31 (0)6 54954623
s.jeurnink@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL489 |
| NTR-old | NTR531 |
| Other | : 945-06-503 |
| ISRCTN | ISRCTN6702358 |