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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00004910
First received: March 7, 2000
Last updated: May 31, 2012
Last verified: May 2012

March 7, 2000
May 31, 2012
January 2000
February 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004910 on ClinicalTrials.gov Archive Site
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Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy

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.

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.

Interventional
Phase 1
Phase 2
Primary Purpose: Supportive Care
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
February 2003
February 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004910
NU 98CC2, NU-98CC2, NCI-G00-1703
Yes
Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: Willis G. Parsons, MD, PC Robert H. Lurie Cancer Center
Northwestern University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP