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

NCT ID: NCT00004911

Last Updated: 2012-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31
• Study Completion Date: 2003-02-28

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.

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.

Conditions

Colorectal Cancer; Constipation, Impaction, and Bowel Obstruction; Gastric Cancer; Gastrointestinal Carcinoid Tumor; Gastrointestinal Stromal Tumor; Quality of Life; Small Intestine Cancer

Study Design

• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

bowel obstruction management

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior or concurrent chemotherapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• Prior or concurrent radiotherapy allowed

Surgery:

• At least 3 weeks since prior surgery and recovered

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Willis G. Parsons, MD, PC

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NU-98CC3

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1704

Identifier Type: -

Identifier Source: secondary_id

NU 98CC3

Identifier Type: -

Identifier Source: org_study_id