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Quality Of Life in Patients With Malignant Biliary Obstruction

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00579865
First received: December 20, 2007
Last updated: January 13, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention
Gallbladder Cancer
Liver Cancer
Bile Duct Cancer
 Behavioral: questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Biliary Drainage on Quality Of Life in Patients With Malignant Biliary Obstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify factors associated with changes in HRQL after drainage(e.g. diagnosis, level of obstruction, degree of pruritus) [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: May 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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. Patients who have undergone bypass or resection will complete an additional set of questionnaires at 9 and 14 weeks.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

MSKCC clinics

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579865

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Piera Robson, RN, BSN Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Piera Robson, RN, BSN, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00579865     History of Changes
Other Study ID Numbers: 04-036
Study First Received: December 20, 2007
Last Updated: January 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Quality of Life

Additional relevant MeSH terms:
Liver Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Liver Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases

ClinicalTrials.gov processed this record on October 17, 2012