Trials / Completed
CompletedNCT00422409
Endoscopic Stenting of Gastrointestinal Cancer
Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 270 (actual)
- Sponsor
- Ullevaal University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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"
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Endoscopic stenting |
Timeline
- Start date
- 2006-10-01
- Primary completion
- 2009-04-01
- Completion
- 2010-04-01
- First posted
- 2007-01-17
- Last updated
- 2011-07-06
Locations
7 sites across 1 country: Norway
Source: ClinicalTrials.gov record NCT00422409. Inclusion in this directory is not an endorsement.