Endoscopic Stenting of Gastrointestinal Cancer

Study Overview
=================
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: 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

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

Conditions
-----------------
Gastrointestinal Neoplasms, Biliary Tract Neoplasms

Intervention / Treatment
-----------------
* Procedure: Endoscopic stenting


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic stenting|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change/improvement i Quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for reintervention |  |  | 
| Change/improvement in gastric emptying |  |  | 
| Rehospitalisations |  |  | 
| Complications |  |  | 
| Death |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SEMS