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Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004911
Recruitment Status : Completed
First Posted : May 14, 2003
Last Update Posted : June 6, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

RATIONALE: The use of endoscopy to place a metal stent in the large intestine is less invasive than surgery for treating cancer-related bowel obstruction and may have fewer side effects and improve recovery.

PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of a metal stent in treating patients who have cancer-related bowel obstruction.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Constipation, Impaction, and Bowel Obstruction Gastric Cancer Gastrointestinal Carcinoid Tumor Gastrointestinal Stromal Tumor Quality of Life Small Intestine Cancer Procedure: bowel obstruction management Procedure: quality-of-life assessment Phase 1 Phase 2

Detailed Description:


  • Determine the objective response and clinical outcome in patients with colonic 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: All patient undergo a colonoscopy, followed by placement of an enteral Wallstent through an endoscope under fluoroscopic guidance into the large intestine.

Quality of life is assessed at 48 hours and 6 months after the 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Supportive Care
Official Title: A Pilot Phase I/II Trial of Enteral Wallstents for Colonic Obstruction in the Setting of Malignancy
Study Start Date : January 2000
Actual Primary Completion Date : February 2003
Actual Study Completion Date : February 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Endoscopically confirmed localized tumor as the cause of colonic obstruction

    • All primary tumor types are eligible
  • No prior colonic Wallstents
  • Must have symptoms of gastrointestinal obstruction, including:

    • Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea



  • 18 and over

Performance status:

  • ECOG 0-3

Life expectancy:

  • Not specified


  • Platelet count greater than 50,000/mm^3


  • INR no greater than 1.5 times upper limit of normal


  • Not specified


  • No cardiac condition


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No significant active infection (e.g., pneumonia, peritonitis, wound abscess) that would preclude endoscopy
  • No other serious concurrent illness
  • No uncontrolled metabolic disease (e.g., diabetes 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


Biologic therapy:

  • Not specified


  • Prior or concurrent chemotherapy allowed

Endocrine therapy:

  • Not specified


  • Prior or concurrent radiotherapy allowed


  • At least 3 weeks since prior surgery and recovered

Information from the National Library of Medicine

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 identifier (NCT number): NCT00004911

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United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
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Study Chair: Willis G. Parsons, MD, PC Robert H. Lurie Cancer Center
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Responsible Party: Northwestern University Identifier: NCT00004911    
Other Study ID Numbers: NU 98CC3
First Posted: May 14, 2003    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: May 2012
Keywords provided by Northwestern University:
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
stage I gastric cancer
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
recurrent gastric cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
localized gastrointestinal carcinoid tumor
regional gastrointestinal carcinoid tumor
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
small intestine adenocarcinoma
small intestine lymphoma
small intestine leiomyosarcoma
recurrent small intestine cancer
constipation, impaction, and bowel obstruction
quality of life
gastrointestinal stromal tumor
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Stromal Tumors
Carcinoid Tumor
Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Intestinal Neoplasms
Intestinal Obstruction
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Stomach Diseases
Signs and Symptoms, Digestive
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue