Endoscopic Stenting of Gastrointestinal Cancer
Primary Purpose
Gastrointestinal Neoplasms, Biliary Tract Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Endoscopic stenting
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Neoplasms focused on measuring SEMS
Eligibility Criteria
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
Sites / Locations
- Sentral Hospital Buskerud
- Sentral Hospital Østfold
- Sykehuset Innlandet Gjøvik
- Sykehuset Innlandet Lillehammer
- Ullevaal University Hospital
- AHUS University Hospital
- Aker University Hospital
Outcomes
Primary Outcome Measures
Change/improvement i Quality of life
Secondary Outcome Measures
Need for reintervention
Change/improvement in gastric emptying
Rehospitalisations
Complications
Death
Full Information
NCT ID
NCT00422409
First Posted
January 16, 2007
Last Updated
July 3, 2011
Sponsor
Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00422409
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 Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ullevaal University Hospital
4. Oversight
5. 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:
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"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms, Biliary Tract Neoplasms
Keywords
SEMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Endoscopic stenting
Primary Outcome Measure Information:
Title
Change/improvement i Quality of life
Secondary Outcome Measure Information:
Title
Need for reintervention
Title
Change/improvement in gastric emptying
Title
Rehospitalisations
Title
Complications
Title
Death
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Truls Hauge, MD,PhD
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sentral Hospital Buskerud
City
Drammen
Country
Norway
Facility Name
Sentral Hospital Østfold
City
Fredrikstad
Country
Norway
Facility Name
Sykehuset Innlandet Gjøvik
City
Gjøvik
Country
Norway
Facility Name
Sykehuset Innlandet Lillehammer
City
Lillehammer
Country
Norway
Facility Name
Ullevaal University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
AHUS University Hospital
City
Oslo
Country
Norway
Facility Name
Aker University Hospital
City
Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Endoscopic Stenting of Gastrointestinal Cancer
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