Spots Global Cancer Trial Database for Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

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Trial Identification

Brief Title: Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

Official Title: A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy

Study ID: NCT00004910

Conditions

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

Interventions

bowel obstruction management

quality-of-life assessment

Study Description

Brief Summary: 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.

Detailed Description: 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.