Quality Of Life in Patients With Malignant Biliary Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gallbladder Cancer Liver Cancer Bile Duct Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Patients scheduled for percutaneous drainage

questionnaires

Intervention Type BEHAVIORAL

complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure.

Group B

Patients scheduled for a surgical bypass or resection of a high bile duct tumor.

questionnaires

Intervention Type BEHAVIORAL

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.

Interventions

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questionnaires

complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure.

Intervention Type BEHAVIORAL

questionnaires

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No