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CompletedNCT00004911Updated Jun 6, 2012

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

A Phase 1/2 interventional study of bowel obstruction management and quality-of-life assessment in Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction and Gastric Cancer, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-06.

Sponsored by Northwestern University · Phase 1/2, Interventional, and Supportive care

Phase
Phase 1/2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • 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.

02

Conditions studied

  • Colorectal Cancer
  • Constipation, Impaction, and Bowel Obstruction
  • Gastric Cancer
  • Gastrointestinal Carcinoid Tumor
  • Gastrointestinal Stromal Tumor
  • Quality of Life
  • Small Intestine Cancer

Keywords

  • 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
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.

Of its 103 completed or terminated interventional studies of FDA-regulated products, 75 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • 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

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, 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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Supportive care

Interventions

  • Procedurebowel obstruction management
  • Procedurequality-of-life assessment
06

Study locations

1 site
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
    Chicago, Illinois 60611-3013, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00004911
Responsible party
Sponsor
First posted
May 14, 2003
Start date
Jan 2000
Primary completion
Feb 2003
Completion
Feb 2003
Last update
Jun 6, 2012

Study contacts

Willis G. Parsons, MD, PC
study chair · Robert H. Lurie Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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