Quality Of Life in Patients With Malignant Biliary Obstruction

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579865
• Other study ID #: 04-036
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: January 13, 2010
• Start date: May 2005
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bile Duct Cancer
• Cholangiocarcinoma
• Gallbladder Cancer
• Liver Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To identify factors associated with changes in HRQL after drainage(e.g. diagnosis, level of obstruction, degree of pruritus)		conclusion of the study	No

External Links

•   Memorial Sloan-Kettering Cancer Center