Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study
The study is divided into four projects:
1. Establish a central register over all patients with malignant GI-obstruction who are
treated with SEMS in the Eastern health region in Norway .Treatment incidence, methods
used, treatment effect,complications related to the procedure,Need for reinterventions,
hospitalisations and survival will be studied.
2. Quality of life(QoL) studies will be performed before and 14 days after treatment.The
EORTC QLQ C30 and EORTCs organospecific modules will be used.
3. Gastric emptying before/after stent will be studied.
4. Evaluate SEMS treatment of acute colon obstruction, as a permanent palliative treatment
or as a "bridge to surgery"
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change/improvement i Quality of life
Truls Hauge, MD,PhD
Ullevaal University Hospital
Norway:National Committee for Medical and Health Research Ethics