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

Status Completed

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.

Clinical Trial 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 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

• NCT number: NCT00422409
• Study type: Interventional
• Source: Oslo University Hospital
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Completion date: April 2010