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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Bile Duct Neoplasms
  • Carcinoid Tumor
  • Cholangiocarcinoma
  • Colorectal Cancer
  • Constipation
  • Constipation, Impaction, and Bowel Obstruction
  • Duodenal Obstruction
  • Extrahepatic Bile Duct Cancer
  • Gastric Cancer
  • Gastrointestinal Carcinoid Tumor
  • Gastrointestinal Neoplasms
  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Tumors
  • Intestinal Obstruction
  • Malignant Carcinoid Syndrome
  • Neuroendocrine Tumors
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Quality of Life
  • Small Intestine Cancer
  • Stomach Neoplasms

NCT number NCT00004910
Study type Interventional
Source Northwestern University
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 2000
Completion date February 2003

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