Bile Duct Cancer, Gallbladder Cancer, Liver Cancer
Conditions
Keywords
Quality of Life
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 description
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.
Interventions
BEHAVIORALquestionnaires
complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of malignant biliary obstruction * Radiologic or histologic evidence of MBO * Percutaneous biliary drainage procedure planned or * Surgical biliary enteric bypass, or hepatic resection with biliary reconstruction (high bile duct tumors) planned * KPS \>50% * Age 18 years or greater * Able to speak and read English * Able to comprehend and execute informed consent * Prior intervention for MBO not exclusionary
Exclusion criteria
* Unable to complete questionnaire due to performance status * Proxy completion is not accepted * Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | conclusion of the study |
Secondary
| Measure | Time frame |
|---|---|
| To identify factors associated with changes in HRQL after drainage(e.g. diagnosis, level of obstruction, degree of pruritus) | conclusion of the study |
Countries
United States
Outcome results
None listed