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
  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 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Study Start Date: January 2000
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
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
Northwestern University
Investigators
Study Chair: Willis G. Parsons, MD, PC Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00004910     History of Changes
Other Study ID Numbers: NU 98CC2, NU-98CC2, NCI-G00-1703
Study First Received: March 7, 2000
Last Updated: May 31, 2012
Health Authority: United States: Federal Government

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 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

Additional relevant MeSH terms:
Malignant Carcinoid Syndrome
Carcinoid Tumor
Colorectal Neoplasms
Constipation
Duodenal Obstruction
Fecal Impaction
Intestinal Obstruction
Stomach Neoplasms
Pancreatic Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Bile Duct Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors
Intestinal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases

ClinicalTrials.gov processed this record on April 16, 2014