Endoscopic Stenting of Gastrointestinal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00422409
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : July 6, 2011
Information provided by:
Oslo University Hospital

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.


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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Neoplasms Biliary Tract Neoplasms Procedure: Endoscopic stenting Not Applicable

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"

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study
Study Start Date : October 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Primary Outcome Measures :
  1. Change/improvement i Quality of life

Secondary Outcome Measures :
  1. Need for reintervention
  2. Change/improvement in gastric emptying
  3. Rehospitalisations
  4. Complications
  5. Death

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00422409

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, 0407
AHUS University Hospital
Oslo, Norway
Aker University Hospital
Oslo, Norway
Sponsors and Collaborators
Ullevaal University Hospital
Study Director: Truls Hauge, MD,PhD Ullevaal University Hospital Identifier: NCT00422409     History of Changes
Other Study ID Numbers: 672
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: April 2007

Keywords provided by Oslo University Hospital:

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Biliary Tract Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Biliary Tract Diseases