Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study
18 Years
N/A
Both
Gastrointestinal Neoplasms, Biliary Tract Neoplasms
Trial Information
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"
Inclusion Criteria:
- Palliative SEMS treatment for malignant GI-obstruction in esophagus,gastroduodenal
region, biliary tractus or colon
- SEMS treatment of acute malignant colon obstruction as a bridge to surgery
Exclusion Criteria:
- Not able to sign informed consent
- SEMS placement in other location last 4 days
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change/improvement i Quality of life
Principal Investigator
Truls Hauge, MD,PhD
Investigator Role:
Study Director
Investigator Affiliation:
Ullevaal University Hospital
Authority:
Norway:National Committee for Medical and Health Research Ethics
Study ID:
672
NCT ID:
NCT00422409
Start Date:
October 2006
Completion Date:
April 2010
Related Keywords:
- Gastrointestinal Neoplasms
- Biliary Tract Neoplasms
- SEMS
- Biliary Tract Neoplasms
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
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