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Cola

bowel obstruction management

quality-of-life assessment

Willis G. Parsons, MD, PC

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.

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.

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

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

National Cancer Institute (NCI)

Northwestern University

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Cholangiocarcinoma

Duodenal Obstruction

Bile Duct Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Duodenal Diseases

Pancreatic Cancer

Bile Duct Cancer

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction	NCT00004911	Colorectal Canc... Constipation, I... Gastric Cancer Gastrointestina... Gastrointestina... Quality of Life Small Intestine...	bowel obstructi... quality-of-life...	18 Years -	Northwestern University
Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction	NCT00004910	Colorectal Canc... Constipation, I... Extrahepatic Bi... Gastric Cancer Gastrointestina... Gastrointestina... Pancreatic Canc... Quality of Life Small Intestine...	bowel obstructi... quality-of-life...	18 Years -	Northwestern University

Spots Global Cancer Trial Database for bowel obstruction management