Quality Of Life in Patients With Malignant Biliary Obstruction

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

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.

Study Overview

• Status: Completed
• Conditions: Bile Duct Cancer; Liver Cancer; Gallbladder Cancer
• Intervention / Treatment: Behavioral: questionnaires; Behavioral: questionnaires

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.

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

MSKCC clinics

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Piera Robson, RN, BSN, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 20, 2007
• First Posted (Estimate): December 24, 2007

Study Record Updates

• Last Update Posted (Estimate): January 14, 2010
• Last Update Submitted That Met QC Criteria: January 13, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Quality of Life
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Gallbladder Diseases; Biliary Tract Diseases; Bile Duct Diseases; Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms; Bile Duct Neoplasms
• Other Study ID Numbers: 04-036