Clinical trial NCT00004910: Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
Official title: A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
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 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
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-05-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Willis G. Parsons, MD, PC
role: STUDY_CHAIR
References: