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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004910
• Other study ID #: NU 98CC2
• Secondary ID: NU-98CC2NCI-G00-
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 7, 2000
• Last updated: May 31, 2012
• Start date: January 2000
• Est. completion date: February 2003

Study information

• Verified date: May 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Carcinoid Tumor
• Cholangiocarcinoma
• Colorectal Cancer
• Constipation
• Constipation, Impaction, and Bowel Obstruction
• Duodenal Obstruction
• Extrahepatic Bile Duct Cancer
• Gastric Cancer
• Gastrointestinal Carcinoid Tumor
• Gastrointestinal Neoplasms
• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Intestinal Obstruction
• Malignant Carcinoid Syndrome
• Neuroendocrine Tumors
• Pancreatic Cancer
• Pancreatic Neoplasms
• Quality of Life
• Small Intestine Cancer
• Stomach Neoplasms

Intervention

Procedure:
• bowel obstruction management

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,