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Spots Global Cancer Trial Database for Endoscopic Stenting of Gastrointestinal Cancer

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Trial Identification

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

Interventions

Endoscopic stenting

Study Description

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"

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Truls Hauge, MD,PhD

Affiliation: Ullevaal University Hospital

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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