Endoscopic Stenting of Gastrointestinal Cancer

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00422409

Enrollment

270

Registered

2007-01-17

Start date

2006-10-31

Completion date

2010-04-30

Last updated

2011-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Neoplasms, Gastrointestinal Neoplasms

Keywords

SEMS

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

Interventions

PROCEDUREEndoscopic stenting

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change/improvement i Quality of life	—

Secondary

Measure	Time frame
Need for reintervention	—
Change/improvement in gastric emptying	—
Rehospitalisations	—
Complications	—
Death	—

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026