Clinical Trials Directory

Trials / Completed

CompletedNCT00004910

Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
—
Sponsor
Northwestern University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than surgery for treating cancer-related duodenal obstruction and may have fewer side effects and improve recovery. PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum.

Detailed description

OBJECTIVES: * Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents. * Evaluate the efficacy and safety of this treatment in these patients. * Evaluate the quality of life of these patients after enteral Wallstent placement. OUTLINE: Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum. Quality of life is assessed at 48 hours and 6 months after procedure. Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
PROCEDUREbowel obstruction management
PROCEDUREquality-of-life assessment

Timeline

Start date
2000-01-01
Primary completion
2003-02-01
Completion
2003-02-01
First posted
2003-05-09
Last updated
2012-06-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00004910. Inclusion in this directory is not an endorsement.