Endoscopic Stenting of Gastrointestinal Cancer

Gastrointestinal Neoplasms Clinical Trial

Official title:

Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422409
• Other study ID #: 672
• Status: Completed
• Phase: N/A
• First received: January 16, 2007
• Last updated: July 3, 2011
• Start date: October 2006
• Est. completion date: April 2010

Study information

• Verified date: April 2007
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: April 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms

Intervention

Procedure:
• Endoscopic stenting

Locations

Country	Name	City	State
Norway	Sentral Hospital Buskerud	Drammen
Norway	Sentral Hospital Østfold	Fredrikstad
Norway	Sykehuset Innlandet Gjøvik	Gjøvik
Norway	Sykehuset Innlandet Lillehammer	Lillehammer
Norway	AHUS University Hospital	Oslo
Norway	Aker University Hospital	Oslo
Norway	Ullevaal University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change/improvement i Quality of life
Secondary	Need for reintervention
Secondary	Change/improvement in gastric emptying
Secondary	Rehospitalisations
Secondary	Complications
Secondary	Death