Quality Of Life in Patients With Malignant Biliary Obstruction

Completed

• Conditions: Gallbladder Cancer; Liver Cancer; Bile Duct Cancer
• Interventions: Behavioral: questionnaires

• Registration Number: NCT00579865
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-24
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	questionnaires	Patients scheduled for percutaneous drainage
Group B	questionnaires	Patients scheduled for a surgical bypass or resection of a high bile duct tumor.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To identify factors associated with changes in HRQL after drainage(e.g. diagnosis, level of obstruction, degree of pruritus)	conclusion of the study

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States