Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Constipation, Impaction, and Bowel Obstruction Extrahepatic Bile Duct Cancer Gastric Cancer Gastrointestinal Carcinoid Tumor Gastrointestinal Stromal Tumor Pancreatic Cancer 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 Duodenal 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 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.
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 duodenal obstruction
- All primary tumor types are eligible
- No prior duodenal 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, or wound abscess) that would preclude endoscopy
- No other serious concurrent illness
- No uncontrolled metabolic disease (e.g., diabetes mellitus 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: | NCT00004910 History of Changes |
| Other Study ID Numbers: | NU 98CC2, NU-98CC2, NCI-G00-1703 |
| 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 pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer recurrent colon 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 localized extrahepatic bile duct cancer unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer recurrent small intestine cancer constipation, impaction, and bowel obstruction quality of life gastrointestinal stromal tumor stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Carcinoid Tumor Colorectal Neoplasms Constipation Duodenal Obstruction Fecal Impaction Intestinal Obstruction Stomach Neoplasms Pancreatic Neoplasms Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Bile Duct 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 |
ClinicalTrials.gov processed this record on May 23, 2013