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Spots Global Cancer Trial Database for Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction

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Trial Identification

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

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

Study ID: NCT00004911

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States

Contact Details

Name: Willis G. Parsons, MD, PC

Affiliation: Robert H. Lurie Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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