Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT00004911

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: The use of endoscopy to place a metal stent in the large intestine is less invasive than surgery for treating cancer-related bowel obstruction and may have fewer side effects and improve recovery.

PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of a metal stent in treating patients who have cancer-related bowel obstruction.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Constipation, Impaction, and Bowel Obstruction Gastric Cancer Gastrointestinal Carcinoid Tumor Gastrointestinal Stromal Tumor Quality of Life Small Intestine Cancer	Procedure: bowel obstruction management Procedure: quality-of-life assessment	Phase 1/Phase 2

Detailed Description

OBJECTIVES:

Determine the objective response and clinical outcome in patients with colonic 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: All patient undergo a colonoscopy, followed by placement of an enteral Wallstent through an endoscope under fluoroscopic guidance into the large intestine.

Quality of life is assessed at 48 hours and 6 months after the 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Feb 1, 2003

Actual Study Completion Date :

Feb 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Endoscopically confirmed localized tumor as the cause of colonic obstruction
All primary tumor types are eligible
No prior colonic Wallstents
Must have symptoms of gastrointestinal obstruction, including:
Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-3

Life expectancy:

Not specified

Hematopoietic:

Platelet count greater than 50,000/mm^3

Hepatic:

INR no greater than 1.5 times upper limit of normal

Renal:

Not specified

Cardiovascular:

No cardiac condition

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No significant active infection (e.g., pneumonia, peritonitis, wound abscess) that would preclude endoscopy
No other serious concurrent illness
No uncontrolled metabolic disease (e.g., diabetes or hypothyroidism)
No dementia, psychiatric disorder, or altered mental status that would preclude compliance
History of other neoplastic disease allowed
Veterans Administration patients are not eligible