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A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Willis G. Parsons, MD, PC

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 98CC2

NCT ID:

NCT00004910

Start Date:

January 2000

Completion Date:

February 2003

Related Keywords:

  • 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
  • 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
  • Carcinoid Tumor
  • Colorectal Neoplasms
  • Constipation
  • Duodenal Obstruction
  • Fecal Impaction
  • Intestinal Obstruction
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Bile Duct Neoplasms
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Gastrointestinal Stromal Tumors
  • Intestinal Neoplasms

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611