Endoscopic Stenting of Gastrointestinal Cancer

Not Applicable

Completed

• Conditions: Gastrointestinal Neoplasms; Biliary Tract Neoplasms

• Registration Number: NCT00422409
• Lead Sponsor: Ullevaal 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.

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:

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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-16
• Study First Posted: 2007-01-17
• Status Verified: 2007-04
• Primary Completion: 2009-04
• Study Completion: 2010-04
• Last Update Submitted: 2011-07-03
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change/improvement i Quality of life

Secondary Outcome Measures

Name	Time	Method
Need for reintervention
Change/improvement in gastric emptying
Rehospitalisations
Complications
Death

Trial Locations

Locations (7)

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

Aker University Hospital; 🇳🇴 Oslo, Norway

AHUS University Hospital; 🇳🇴 Oslo, Norway