A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy
18 Years
N/A
Both
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
Trial Information
A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
Willis G. Parsons, MD, PC
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
NU 98CC2
NCT ID:
NCT00004910
Start Date:
January 2000
Completion Date:
February 2003
Related Keywords:
- 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
- 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
- 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
Name | Location |
|---|---|
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
