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Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction Clinical research trials and Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction. Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction clinical trial. Test subjects typically receive the most expert healthcare available for their Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction  Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
For Condition: Colon Cancer,Pancreatic Cancer,Colorectal Cancer,Gastric Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents. II. Evaluate the efficacy and safety of this treatment in these patients. III. Evaluate the quality of life of these patients after enteral Wallstent placement. PROTOCOL 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:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Platelet count greater than 50,000/mm3 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WillisParsons, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Additional Information:
Study ID Numbers: CDR0000067590; NU-98CC2,NCI-G00-1703
Study Start Date: January 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004910
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Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
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