Surgery versus stent for malignant gastro-duodenal obstruction.

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.

To compare a surgical procedure (gastrojejunostomy, GJJ) with endoscopical stent placement in patients with malignant gastric outlet obstruction (GOO)

1. Duodenal stent placement;
2. Gastrojejunostomy.