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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004910
  Purpose

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 Intervention 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 I
Phase II

MedlinePlus related topics:   Cancer    Carcinoid Tumors    Colorectal Cancer    Constipation    Endoscopy    Intestinal Cancer    Pancreatic Cancer    Stomach Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care
Official Title:   A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   January 2000

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004910

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University    
      Chicago, Illinois, United States, 60611-3013

Sponsors and Collaborators
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Willis G. Parsons, MD, PC     Robert H. Lurie Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067590, NU-98CC2, NCI-G00-1703
First Received:   March 7, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004910
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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 pancreatic cancer  
stage II pancreatic cancer  
stage III pancreatic cancer  
recurrent pancreatic cancer  
recurrent colon 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
localized extrahepatic bile duct cancer
unresectable extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
recurrent small intestine cancer
constipation, impaction, and bowel obstruction
quality of life
gastrointestinal stromal tumor
stage IV pancreatic cancer

Study placed in the following topic categories:
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Leiomyosarcoma
Pancreatic Neoplasms
Colonic Diseases
Quality of Life
Rectal Diseases
Duodenal Neoplasms
Intestinal Obstruction
Signs and Symptoms
Stomach Diseases
Ileal Neoplasms
Biliary Tract Diseases
Stomach Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Lymphoma
Duodenal Diseases
Endocrine Gland Neoplasms
Bile duct cancer, extrahepatic
Jejunal Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Serotonin Syndrome
Endocrine System Diseases
Stomach cancer
Malignant Carcinoid Syndrome
Intestinal Diseases
Carcinoid syndrome
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Jejunal Diseases
Neoplasms, Nerve Tissue
Ileal Diseases

ClinicalTrials.gov processed this record on August 27, 2008




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