Quality Of Life in Patients With Malignant Biliary Obstruction

Study Overview
=================
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.

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

Conditions
-----------------
Gallbladder Cancer, Liver Cancer, Bile Duct Cancer

Intervention / Treatment
-----------------
* Behavioral: questionnaires
* Behavioral: questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Patients scheduled for percutaneous drainage | Behavioral: questionnaires<br>* complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure.<br>|
| Group B<br>Patients scheduled for a surgical bypass or resection of a high bile duct tumor. | Behavioral: questionnaires<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life