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

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

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.

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.

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