Quality Of Life in Patients With Malignant Biliary Obstruction
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Impact of Biliary Drainage on Quality Of Life in Patients With Malignant Biliary Obstruction|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Patients scheduled for percutaneous drainage
complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure.
Patients scheduled for a surgical bypass or resection of a high bile duct tumor.
complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure. Patients who have undergone bypass or resection will complete an additional set of questionnaires at 9 and 14 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579865
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Piera Robson, RN, BSN||Memorial Sloan-Kettering Cancer Center|