Endoscopic Stenting of Gastrointestinal Cancer - Full Text View

Sponsored by:	Ullevaal University Hospital
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00422409

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

MedlinePlus related topics: Cancer Endoscopy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Palliative Endoscopic Treatment of Malignant GI-Strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study

Further study details as provided by Ullevaal 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

Estimated Enrollment:	100
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2008

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"

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

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

Contacts

Contact: Lene Larssen, MD	+4793041073	lene.larssen@medisin.uio.no
Contact: Truls Hauge, MD,PhD	+4722119100	truls.hauge@ulleval.no

Locations

Norway
Ullevaal University Hospital	Recruiting
Oslo, Norway, 0407
Contact: Lene Larssen, MD +4793041073 lene.larssen@medisin.uio.no
Principal Investigator: Lene Larssen, MD
Aker University Hospital	Recruiting
Oslo, Norway
AHUS University Hospital	Recruiting
Oslo, Norway
Sykehuset Innlandet Gjøvik	Recruiting
Gjøvik, Norway
Sentral Hospital Østfold	Recruiting
Fredrikstad, Norway
Sykehuset Innlandet Lillehammer	Recruiting
Lillehammer, Norway
Sentral Hospital Buskerud	Recruiting
Drammen, Norway

Sponsors and Collaborators

Ullevaal University Hospital

Investigators

Study Director:

Truls Hauge, MD,PhD

Ullevaal University Hospital

More Information

Study ID Numbers:	672
Study First Received:	January 16, 2007
Last Updated:	January 16, 2007
ClinicalTrials.gov Identifier:	NCT00422409
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Ullevaal University Hospital:

SEMS

Study placed in the following topic categories:

Digestive System Diseases
Biliary Tract Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases

Biliary Tract Diseases
Gastrointestinal Neoplasms
Constriction, Pathologic

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009