Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | 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: | January 2000 |
| Study Completion Date: | February 2003 |
| Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Study Chair: | Willis G. Parsons, MD, PC | Robert H. Lurie Cancer Center |
More Information
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004911 History of Changes |
| Other Study ID Numbers: | NU 98CC3, NU-98CC3, NCI-G00-1704 |
| Study First Received: | March 7, 2000 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Northwestern University:
|
stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon cancer stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer recurrent gastric cancer stage I rectal cancer stage II rectal cancer stage III rectal cancer stage IV rectal cancer |
recurrent colon cancer recurrent rectal cancer localized gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor small intestine adenocarcinoma small intestine lymphoma small intestine leiomyosarcoma recurrent small intestine cancer constipation, impaction, and bowel obstruction quality of life gastrointestinal stromal tumor |
Additional relevant MeSH terms:
|
Carcinoid Tumor Colorectal Neoplasms Constipation Fecal Impaction Intestinal Obstruction Stomach Neoplasms Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Malignant Carcinoid Syndrome Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Intestinal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Signs and Symptoms, Digestive |
ClinicalTrials.gov processed this record on June 13, 2013