Clinical Trial: Quality Of Life in Patients With Malignant Biliary Obstruction

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Impact of Biliary Drainage on Quality Of Life in Patients With Malignant Biliary Obstruction

Brief Summary: You may have symptoms like itching, abdominal pain, loss of appetite, fatigue, fevers and chills. The treatment you will receive to relieve the blockage is also intended to relieve symptoms and improve your quality of life. The purpose of this study is to find out if relieving the blockage in your bile duct improves your quality of life.

Detailed Summary: Malignant biliary obstruction (MBO) may arise in patients with cholangiocarcinoma, pancreatic carcinoma, primary gallbladder carcinoma, hepatocellular carcinoma, or metastatic disease to the liver or portal lymph nodes. MBO is often accompanied by significant symptoms that may result in impairment of health-related quality of life (HRQL), including pruritus, fever, nutritional deficits, abdominal pain, nausea and vomiting, and fatigue. Approaches to the relief of MBO include surgical bypass and/or resection, percutaneous drainage with or without biliary stenting, or endoscopic stenting. The non surgical procedures may be done prior to attempted curative resection or for palliation in individuals with unresectable or recurrent disease.
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: To determine how surgical or percutaneous drainage affects HRQL scores in patients with MBO, and to determine if these changes are sustained or change over time. [ Time Frame: conclusion of the study ]

Original Primary Outcome: To determine how surgical or percutaneous drainage affects HRQL scores in patients with MBO, and to determine if these changes are sustained or change over time.

Current Secondary Outcome: To identify factors associated with changes in HRQL after drainage(e.g. diagnosis, level of obstruction, degree of pruritus) [ Time Frame: conclusion of the study ]

Original Secondary Outcome: To identify factors associated with changes in HRQL after drainage(e.g. diagnosis, level of obstruction, degree of pruritus)

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: December 20, 2007
Date Started: May 2005
Date Completion:
Last Updated: January 13, 2010
Last Verified: January 2010