Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
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|ClinicalTrials.gov Identifier: NCT00004910|
Recruitment Status : Completed
First Posted : May 9, 2003
Last Update Posted : June 6, 2012
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 or disease||Intervention/treatment||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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||February 2003|
|Actual Study Completion Date :||February 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004910
|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|