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

18 Years
Not Enrolling
Gallbladder Cancer, Liver Cancer, Bile Duct Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

conclusion of the study

Safety Issue:


Principal Investigator

Piera Robson, RN, BSN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

January 2010

Related Keywords:

  • Gallbladder Cancer
  • Liver Cancer
  • Bile Duct Cancer
  • Quality of Life
  • Liver Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021