NCT00422409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 6, 2011

Status Verified

April 1, 2007

Enrollment Period

2.5 years

First QC Date

January 16, 2007

Last Update Submit

July 3, 2011

Conditions

Gastrointestinal NeoplasmsBiliary Tract Neoplasms

Keywords

SEMS

Outcome Measures

Primary Outcomes (1)

  • Change/improvement i Quality of life

Secondary Outcomes (5)

  • Need for reintervention

  • Change/improvement in gastric emptying

  • Rehospitalisations

  • Complications

  • Death

Interventions

Endoscopic stentingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not able to sign informed consent
  • SEMS placement in other location last 4 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Sentral Hospital Buskerud

Drammen, Norway

Location

Sentral Hospital Østfold

Fredrikstad, Norway

Location

Sykehuset Innlandet Gjøvik

Gjøvik, Norway

Location

Sykehuset Innlandet Lillehammer

Lillehammer, Norway

Location

Ullevaal University Hospital

Oslo, 0407, Norway

Location

AHUS University Hospital

Oslo, Norway

Location

Aker University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Gastrointestinal NeoplasmsBiliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesBiliary Tract Diseases

Study Officials

  • Truls Hauge, MD,PhD

    Ullevaal University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2007

First Posted

January 17, 2007

Study Start

October 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2010

Last Updated

July 6, 2011

Record last verified: 2007-04

Locations

NO(7)