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Brief Title: Endoscopic Stenting of Gastrointestinal Cancer
Official Title: Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study
Study ID: NCT00422409
Brief Summary: Obstruction of the digestive tract is a frequent cause of morbidity in patients with gastrointestinal cancer.Palliative endoscopic treatment with self- expanding metal stents(SEMS)is an alternative to palliative surgery and other palliative treatment options.The method has expanded to include patients with malignancies in the esophagus,gastroduodenal region, biliary tractus and colon. Numerous retrospective studies have reported treatment with SEMS to be safe and effective. Prospective studies,and especially studies regarding Quality of Life improvement are needed. PURPOSE: The purpose of this trial is to prospectively study the use and effect of selfexpanding metal stents(SEMS)in a defined population i Norway, especially Quality of Life changes.
Detailed Description: 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"
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sentral Hospital Buskerud, Drammen, , Norway
Sentral Hospital Østfold, Fredrikstad, , Norway
Sykehuset Innlandet Gjøvik, Gjøvik, , Norway
Sykehuset Innlandet Lillehammer, Lillehammer, , Norway
Ullevaal University Hospital, Oslo, , Norway
AHUS University Hospital, Oslo, , Norway
Aker University Hospital, Oslo, , Norway
Name: Truls Hauge, MD,PhD
Affiliation: Ullevaal University Hospital
Role: STUDY_DIRECTOR