Endoscopic Stenting of Gastrointestinal Cancer

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00422409
First received: January 16, 2007
Last updated: July 3, 2011
Last verified: April 2007
  Purpose

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.


Condition Intervention
Gastrointestinal Neoplasms
Biliary Tract Neoplasms
Procedure: Endoscopic stenting

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Change/improvement i Quality of life

Secondary Outcome Measures:
  • Need for reintervention
  • Change/improvement in gastric emptying
  • Rehospitalisations
  • Complications
  • Death

Enrollment: 270
Study Start Date: October 2006
Study Completion Date: April 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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"
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422409

Locations
Norway
Sentral Hospital Buskerud
Drammen, Norway
Sentral Hospital Østfold
Fredrikstad, Norway
Sykehuset Innlandet Gjøvik
Gjøvik, Norway
Sykehuset Innlandet Lillehammer
Lillehammer, Norway
Aker University Hospital
Oslo, Norway
Ullevaal University Hospital
Oslo, Norway, 0407
AHUS University Hospital
Oslo, Norway
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Director: Truls Hauge, MD,PhD Ullevaal University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00422409     History of Changes
Other Study ID Numbers: 672
Study First Received: January 16, 2007
Last Updated: July 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
SEMS

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

ClinicalTrials.gov processed this record on July 20, 2014