Clinical trial NCT00422409: Endoscopic Stenting of Gastrointestinal Cancer
Official title: Palliative Endoscopic Treatment of Malignant GI-strictures With Self Expanding Metal Stents(SEMS)-a Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Neoplasms
Biliary Tract Neoplasms
Keywords: SEMS
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2007-01-17
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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"

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

Primary outcomes:
measure: Change/improvement i Quality of life
Secondary outcomes:
measure: Need for reintervention
measure: Change/improvement in gastric emptying
measure: Rehospitalisations
measure: Complications
measure: Death
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Sentral Hospital Buskerud
city: Fredrikstad
country: Norway
facility: Sentral Hospital Østfold
city: Gjøvik
country: Norway
facility: Sykehuset Innlandet Gjøvik
city: Lillehammer
country: Norway
facility: Sykehuset Innlandet Lillehammer
city: Oslo
country: Norway
facility: Ullevaal University Hospital
city: Oslo
country: Norway
facility: AHUS University Hospital
city: Oslo
country: Norway
facility: Aker University Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Truls Hauge, MD,PhD
role: STUDY_DIRECTOR
References: