Endoscopic Stenting of Gastrointestinal Cancer
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.
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.
Biliary Tract Neoplasms
Procedure: Endoscopic stenting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study|
- Change/improvement i Quality of life
- Need for reintervention
- Change/improvement in gastric emptying
|Study Start Date:||October 2006|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
The study is divided into four projects:
- 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.
- 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.
- Gastric emptying before/after stent will be studied.
- Evaluate SEMS treatment of acute colon obstruction, as a permanent palliative treatment or as a "bridge to surgery"
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422409
|Sentral Hospital Buskerud|
|Sentral Hospital Østfold|
|Sykehuset Innlandet Gjøvik|
|Sykehuset Innlandet Lillehammer|
|Aker University Hospital|
|Ullevaal University Hospital|
|Oslo, Norway, 0407|
|AHUS University Hospital|
|Study Director:||Truls Hauge, MD,PhD||Ullevaal University Hospital|